← Back to catalogue
Kheiron
EUDAMEDFDA UDIClass I (EU MDR)
Ref PC0030Ref 24BT0010Ref 24FE1031Ref FC0025Ref 24BT0020Ref 24CR3050Ref 24PB1025Ref 24HE2040Ref 24BT0040Ref 24BT0050Ref 24TP1075Ref 24BT0120Ref 24BT0090Ref 24FE1030Ref 24PW45045Ref 24SA1015Ref PA0040Ref 24BT0100Ref 24CH2020Ref 24BT0080Ref FC0020Ref 24BT0060Ref 24DD4020Ref 24TP1065Ref 24PD2010Ref 24IB3060Ref 24PB1020Ref 24TP1055Ref 24HR1080Ref 32KR55000Ref 24PW95085Ref 24PW85075Ref 27PC55110Ref 24PW95080Ref 25SW65080Ref 25SP55901Ref 01GN2060Ref 01DR3020Ref 01DS2020Ref 24PW95075Ref 28IW15055Ref 01BS0012Ref 01RK0011Ref 28IW15070Ref 24IB3065Ref 27PC52170Ref 01BS0115Ref 24CR55445Ref 26PH45100Ref 25SW65040Ref 01ST1010Ref 28IW85070Ref 01GN2050Ref 01BS0001Ref 27PC53170Ref 24DW3030Ref 24PW95095Ref 24BR55045Ref 26SP45100Ref 28IW65055Ref 24DN2070Ref 01RK0030Ref 24BR60045Ref 26TC10075Ref 24SR55035Ref 26PH45130Ref 25SW75030Ref 29TC55101Ref 27PC54095Ref 24PW75060Ref 24CR55615Ref 28IW85065Ref 28IW15110Ref 27PC52075Ref 24PB3082Ref 24BR60075Ref 24SR60095Ref 25SW75035
by S.m.a.i.o
Identity
- Trade Name
- KHEIRON EUDAMEDFDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDISurgical instrument/implant rack FDA UDIBone-screw internal spinal fixation system hook FDA UDIBone-screw internal spinal fixation system connector FDA UDIInternal spinal fixation procedure kit, reusable FDA UDIBone-screw internal spinal fixation system rod FDA UDISpinal fixation plate, non-bioabsorbable FDA UDIOrthopaedic osteotome FDA UDISurgical screwdriver, reusable FDA UDIBone distraction forceps FDA UDI
- Device Name
- Pince Porte Tige EUDAMEDBase pour préparation pédiculaire EUDAMEDPalpateur droit EUDAMEDFer à cintrer coronal gauche pour tiges Ø5.5 EUDAMEDBase pour Positionnement des tiges EUDAMEDPince de Compression EUDAMEDSonde Pédiculaire Courbe EUDAMEDPoignée pour Extension Droites EUDAMEDRack pour vis EUDAMEDRack pour crosslinks EUDAMEDTaraud pour vis Ø7.5 EUDAMEDBase pour implants EUDAMEDRack pour tiges cintrées EUDAMEDJauge de profondeur pour palpateur droit EUDAMEDVis pédiculaire Ø4.5 L45mm EUDAMEDPointe Carrée Courte EUDAMEDMarqueur pédiculaire EUDAMEDCouvercle pour rack pour tiges cintrées EUDAMEDPorte Connecteur - Post EUDAMEDCouvercle pour rack pour connecteurs et écrous EUDAMEDFer à cintrer coronal droit pour tiges Ø5.5 EUDAMEDCouvercle pour rack pour crosslinks EUDAMEDTourne-écrou de révision EUDAMEDTaraud pour vis Ø6.5 EUDAMEDTournevis Pédiculaire - Post EUDAMEDFer à cintrer sagittal droite pour tiges Ø5.5 EUDAMEDSonde pédiculaire droite EUDAMEDTaraud pour vis Ø5.5 EUDAMEDPoignée à Cliquet EUDAMEDØ5.5 patient-specific K-ROD Ti rod EUDAMEDVis pédiculaire Ø9.5 L85mm EUDAMEDVis pédiculaire Ø8.5 L75mm EUDAMEDConnecteur tulipe parallèle 11mm EUDAMEDVis pédiculaire Ø9.5 L80mm EUDAMEDVis sacrée Ø6.5 L80mm EUDAMEDPlaque sacrée droite 90° EUDAMEDGuide pour bouchon S2 gauche 90° pour plaque sacrée L EUDAMEDPince de distraction EUDAMEDTournevis pédiculaire EUDAMEDVis pédiculaire Ø9.5 L75mm EUDAMEDVis iliaque Ø10.5 L55mm EUDAMEDGrande base pour implants EUDAMEDRack pour vis pédiculaires #1 EUDAMEDVis iliaque Ø10.5 L70mm EUDAMEDFer à cintrer sagittal gauche pour tiges Ø5.5 EUDAMEDConnecteur parallèle fermé/fermé 17mm EUDAMEDBase pour instruments #5 - Crochets et extensions iliaques EUDAMEDTige cintrée Ti Ø5.5 40° L50-450mm EUDAMEDCrochet pédiculaire petit, court pour pince EUDAMEDVis sacrée Ø6.5 L40mm EUDAMEDOstéotome angulé EUDAMEDVis iliaque Ø8.5 L70mm EUDAMEDGuide pour bouchon S2 droite 90° pour plaque sacrée L EUDAMEDCouvercle pour base EUDAMEDConnecteur parallèle ouvert/fermé 17mm EUDAMEDClé de dérotation EUDAMEDVis pédiculaire Ø9.5 L95mm EUDAMEDTige cintrée Ti Ø5.5 L45mm EUDAMEDCrochet pédiculaire petit, court EUDAMEDVis iliaque Ø6.5 L55mm EUDAMEDTournevis pour Ecrou - Post EUDAMEDRack pour plaques sacrées EUDAMEDTige cintrée Ti Ø6 L45mm EUDAMEDContre-crochet gauche, moyen EUDAMEDTige droite Ti Ø5.5 L35mm EUDAMEDCrochet pédiculaire petit, long pour pince EUDAMEDVis sacrée Ø7.5 L30mm EUDAMEDConnecteur transverse H pour tige Ø5.5 taille 1 EUDAMEDConnecteur parallèle ouvert/ouvert 9.5mm EUDAMEDVis pédiculaire Ø7.5 L60mm EUDAMEDTige cintrée Ti Ø5.5 65° L150-150mm EUDAMEDVis iliaque Ø8.5 L65mm EUDAMEDVis iliaque Ø10.5 L110mm EUDAMEDConnecteur parallèle fermé/fermé 7.5mm EUDAMEDTube pour Tournevis de Serrage Final - Post EUDAMEDTige cintrée Ti Ø6 L75mm EUDAMEDTige droite Ti Ø6 L95mm EUDAMEDVis sacrée Ø7.5 L35mm EUDAMEDØ10.5 L55mm iliac screw FDA UDIØ9.5 L75mm pedicle screw FDA UDILarge implants tray FDA UDILeft, medium counterhook FDA UDISmall, long claw pedicle hook FDA UDI17mm open/closed parallel connector FDA UDIRight 90° S2 cap guide for sacral plate L FDA UDIØ7.5 L30mm sacral screw FDA UDIØ5.5 L35mm straight Ti rod FDA UDIØ8.5 L70mm iliac screw FDA UDIRight 90° sacral plate FDA UDISmall, short pedicle hook FDA UDIØ5.5 40° L50-450mm curved Ti rod FDA UDIØ5.5 65° L150-150mm curved Ti rod FDA UDIØ7.5 L60mm pedicle screw FDA UDISacral plates rack FDA UDIØ10.5 L70mm iliac screw FDA UDIAngulated osteotome FDA UDIØ5.5 L45mm pre bent Ti rod FDA UDIØ6.5 L40mm sacral screw FDA UDIØ8.5 L65mm iliac screw FDA UDIØ6 L75mm pre bent Ti rod FDA UDISmall, short claw pedicle hook FDA UDIØ6 L45mm pre bent Ti rod FDA UDIØ9.5 L85mm pedicle screw FDA UDI9.5mm open/open parallel connector FDA UDITray cover FDA UDIPost Nut Driver FDA UDI7.5mm closed/closed parallel connector FDA UDIPedicle screwdriver FDA UDI11mm parallel tulip connector FDA UDI#5 instruments tray - Hooks and iliac extensions FDA UDIØ10.5 L110mm iliac screw FDA UDIØ4.5 L45mm pedicle screw FDA UDIØ6.5 L55mm iliac screw FDA UDIØ5.5 size 1 H transverse connector FDA UDI17mm closed/closed parallel connector FDA UDIDistractor FDA UDILeft 90° S2 cap guide for sacral plate L FDA UDIØ9.5 L80mm pedicle screw FDA UDI#1 pedicle screws rack FDA UDIØ6.5 L80mm sacral screw FDA UDIØ6 L95mm straight Ti rod FDA UDIØ9.5 L95mm pedicle screw FDA UDIØ8.5 L75mm pedicle screw FDA UDIØ7.5 L35mm sacral screw FDA UDI
- Model / Reference
- PC0030 EUDAMED24BT0010 EUDAMED24FE1031 EUDAMEDFC0025 EUDAMED24BT0020 EUDAMED24CR3050 EUDAMED24PB1025 EUDAMED24HE2040 EUDAMED24BT0040 EUDAMED24BT0050 EUDAMED24TP1075 EUDAMED24BT0120 EUDAMED24BT0090 EUDAMED24FE1030 EUDAMED24PW45045 EUDAMEDFDA UDI24SA1015 EUDAMEDPA0040 EUDAMED24BT0100 EUDAMED24CH2020 EUDAMED24BT0080 EUDAMEDFC0020 EUDAMED24BT0060 EUDAMED24DD4020 EUDAMED24TP1065 EUDAMED24PD2010 EUDAMED24IB3060 EUDAMED24PB1020 EUDAMED24TP1055 EUDAMED24HR1080 EUDAMED32KR55000 EUDAMED28IW15055 EUDAMEDFDA UDI24PW95075 EUDAMEDFDA UDI01BS0012 EUDAMEDFDA UDI26TC10075 EUDAMEDFDA UDI26PH45130 EUDAMEDFDA UDI27PC53170 EUDAMEDFDA UDI01GN2050 EUDAMEDFDA UDI25SW75030 EUDAMEDFDA UDI24SR55035 EUDAMEDFDA UDI28IW85070 EUDAMEDFDA UDI25SP55901 EUDAMEDFDA UDI26SP45100 EUDAMEDFDA UDI24CR55445 EUDAMEDFDA UDI24CR55615 EUDAMEDFDA UDI24PW75060 EUDAMEDFDA UDI01RK0030 EUDAMEDFDA UDI28IW15070 EUDAMEDFDA UDI01ST1010 EUDAMEDFDA UDI24BR55045 EUDAMEDFDA UDI25SW65040 EUDAMEDFDA UDI28IW85065 EUDAMEDFDA UDI24BR60075 EUDAMEDFDA UDI26PH45100 EUDAMEDFDA UDI24BR60045 EUDAMEDFDA UDI24PW95085 EUDAMEDFDA UDI27PC54095 EUDAMEDFDA UDI01BS0001 EUDAMEDFDA UDI27PC52075 EUDAMEDFDA UDI01DS2020 EUDAMEDFDA UDI27PC55110 EUDAMEDFDA UDI01BS0115 EUDAMEDFDA UDI28IW15110 EUDAMEDFDA UDI28IW65055 EUDAMEDFDA UDI29TC55101 EUDAMEDFDA UDI27PC52170 EUDAMEDFDA UDI01DR3020 EUDAMEDFDA UDI01GN2060 EUDAMEDFDA UDI24PW95080 EUDAMEDFDA UDI01RK0011 EUDAMEDFDA UDI25SW65080 EUDAMEDFDA UDI24SR60095 EUDAMEDFDA UDI24PW95095 EUDAMEDFDA UDI24PW85075 EUDAMEDFDA UDI25SW75035 EUDAMEDFDA UDI24IB3065 EUDAMED24DW3030 EUDAMED24DN2070 EUDAMED24PB3082 EUDAMED24ND2070 FDA UDI
- Description
- Ø10.5 L55mm iliac screw FDA UDIØ9.5 L75mm pedicle screw FDA UDILarge implants tray FDA UDILeft, medium counterhook FDA UDISmall, long claw pedicle hook FDA UDI17mm open/closed parallel connector FDA UDIRight 90° S2 cap guide for sacral plate L FDA UDIØ7.5 L30mm sacral screw FDA UDIØ5.5 L35mm straight Ti rod FDA UDIØ8.5 L70mm iliac screw FDA UDIRight 90° sacral plate FDA UDISmall, short pedicle hook FDA UDIØ5.5 40° L50-450mm curved Ti rod FDA UDIØ5.5 65° L150-150mm curved Ti rod FDA UDIØ7.5 L60mm pedicle screw FDA UDISacral plates rack FDA UDIØ10.5 L70mm iliac screw FDA UDIAngulated osteotome FDA UDIØ5.5 L45mm pre bent Ti rod FDA UDIØ6.5 L40mm sacral screw FDA UDIØ8.5 L65mm iliac screw FDA UDIØ6 L75mm pre bent Ti rod FDA UDISmall, short claw pedicle hook FDA UDIØ6 L45mm pre bent Ti rod FDA UDIØ9.5 L85mm pedicle screw FDA UDI9.5mm open/open parallel connector FDA UDITray cover FDA UDIPost Nut Driver FDA UDI7.5mm closed/closed parallel connector FDA UDIPedicle screwdriver FDA UDI11mm parallel tulip connector FDA UDI#5 instruments tray - Hooks and iliac extensions FDA UDIØ10.5 L110mm iliac screw FDA UDIØ4.5 L45mm pedicle screw FDA UDIØ6.5 L55mm iliac screw FDA UDIØ5.5 size 1 H transverse connector FDA UDI17mm closed/closed parallel connector FDA UDIDistractor FDA UDILeft 90° S2 cap guide for sacral plate L FDA UDIØ9.5 L80mm pedicle screw FDA UDI#1 pedicle screws rack FDA UDIØ6.5 L80mm sacral screw FDA UDIØ6 L95mm straight Ti rod FDA UDIØ9.5 L95mm pedicle screw FDA UDIØ8.5 L75mm pedicle screw FDA UDIØ7.5 L35mm sacral screw FDA UDI
Identifiers
- Catalog Number
- 28IW15055 FDA UDI24PW95075 FDA UDI01BS0012 FDA UDI26TC10075 FDA UDI26PH45130 FDA UDI27PC53170 FDA UDI01GN2050 FDA UDI25SW75030 FDA UDI24SR55035 FDA UDI28IW85070 FDA UDI25SP55901 FDA UDI26SP45100 FDA UDI24CR55445 FDA UDI24CR55615 FDA UDI24PW75060 FDA UDI01RK0030 FDA UDI28IW15070 FDA UDI01ST1010 FDA UDI24BR55045 FDA UDI25SW65040 FDA UDI28IW85065 FDA UDI24BR60075 FDA UDI26PH45100 FDA UDI24BR60045 FDA UDI24PW95085 FDA UDI27PC54095 FDA UDI01BS0001 FDA UDI27PC52075 FDA UDI01DS2020 FDA UDI27PC55110 FDA UDI01BS0115 FDA UDI28IW15110 FDA UDI24PW45045 FDA UDI28IW65055 FDA UDI29TC55101 FDA UDI27PC52170 FDA UDI01DR3020 FDA UDI01GN2060 FDA UDI24PW95080 FDA UDI01RK0011 FDA UDI25SW65080 FDA UDI24SR60095 FDA UDI24PW95095 FDA UDI24PW85075 FDA UDI25SW75035 FDA UDI
- Primary DI / UDI-DI
- 03701313001483 EUDAMED03701313001636 EUDAMED03701313001353 EUDAMED03701313001575 EUDAMED03701313001643 EUDAMED03701313001537 EUDAMED03701313001339 EUDAMED03701313001476 EUDAMED03701313001667 EUDAMED03701313001674 EUDAMED03701313001421 EUDAMED03701313001742 EUDAMED03701313001711 EUDAMED03701313001346 EUDAMED03701313000783 EUDAMEDFDA UDI03701313001315 EUDAMED03701313001377 EUDAMED03701313001728 EUDAMED03701313001445 EUDAMED03701313001704 EUDAMED03701313001568 EUDAMED03701313001681 EUDAMED03701313001612 EUDAMED03701313001414 EUDAMED03701313001438 EUDAMED03701313001544 EUDAMED03701313001322 EUDAMED03701313001407 EUDAMED03701313001629 EUDAMED03701313000455 EUDAMED03701313004262 EUDAMEDFDA UDI03701313003869 EUDAMEDFDA UDI03701313001988 EUDAMEDFDA UDI03701313004798 EUDAMEDFDA UDI03701313004842 EUDAMEDFDA UDI03701313002473 EUDAMEDFDA UDI03701313000349 EUDAMEDFDA UDI03701313002954 EUDAMEDFDA UDI03701313000189 EUDAMEDFDA UDI03701313004415 EUDAMEDFDA UDI03701313003128 EUDAMEDFDA UDI03701313004736 EUDAMEDFDA UDI03701313005023 EUDAMEDFDA UDI03701313000080 EUDAMEDFDA UDI03701313001087 EUDAMEDFDA UDI03701313002749 EUDAMEDFDA UDI03701313004231 EUDAMEDFDA UDI03701313002725 EUDAMEDFDA UDI03701313001865 EUDAMEDFDA UDI03701313003029 EUDAMEDFDA UDI03701313004422 EUDAMEDFDA UDI03701313003500 EUDAMEDFDA UDI03701313004859 EUDAMEDFDA UDI03701313003531 EUDAMEDFDA UDI03701313003845 EUDAMEDFDA UDI03701313002459 EUDAMEDFDA UDI03701313001995 EUDAMEDFDA UDI03701313001490 EUDAMEDFDA UDI03701313002589 EUDAMEDFDA UDI03701313002237 EUDAMEDFDA UDI03701313002404 EUDAMEDFDA UDI03701313004989 EUDAMEDFDA UDI03701313004187 EUDAMEDFDA UDI03701313004620 EUDAMEDFDA UDI03701313005283 EUDAMEDFDA UDI03701313002534 EUDAMEDFDA UDI03701313002091 EUDAMEDFDA UDI03701313000332 EUDAMEDFDA UDI03701313003852 EUDAMEDFDA UDI03701313001926 EUDAMEDFDA UDI03701313003777 EUDAMEDFDA UDI03701313003333 EUDAMEDFDA UDI03701313003821 EUDAMEDFDA UDI03701313004026 EUDAMEDFDA UDI03701313002947 EUDAMEDFDA UDI03701313001551 EUDAMED03701313001513 EUDAMED03701313001599 EUDAMED
- Basic UDI-DI
- B-03701313001483 EUDAMEDB-03701313001636 EUDAMEDB-03701313001353 EUDAMEDB-03701313001575 EUDAMEDB-03701313001643 EUDAMEDB-03701313001537 EUDAMEDB-03701313001339 EUDAMEDB-03701313001476 EUDAMEDB-03701313001667 EUDAMEDB-03701313001674 EUDAMEDB-03701313001421 EUDAMEDB-03701313001742 EUDAMEDB-03701313001711 EUDAMEDB-03701313001346 EUDAMEDB-03701313000783 EUDAMEDB-03701313001315 EUDAMEDB-03701313001377 EUDAMEDB-03701313001728 EUDAMEDB-03701313001445 EUDAMEDB-03701313001704 EUDAMEDB-03701313001568 EUDAMEDB-03701313001681 EUDAMEDB-03701313001612 EUDAMEDB-03701313001414 EUDAMEDB-03701313001438 EUDAMEDB-03701313001544 EUDAMEDB-03701313001322 EUDAMEDB-03701313001407 EUDAMEDB-03701313001629 EUDAMEDB-03701313000455 EUDAMEDB-03701313003845 EUDAMEDB-03701313004026 EUDAMEDB-03701313002404 EUDAMEDB-03701313003852 EUDAMEDB-03701313003777 EUDAMEDB-03701313003128 EUDAMEDB-03701313000332 EUDAMEDB-03701313002091 EUDAMEDB-03701313002237 EUDAMEDB-03701313003869 EUDAMEDB-03701313004262 EUDAMEDB-03701313001988 EUDAMEDB-03701313001926 EUDAMEDB-03701313004231 EUDAMEDB-03701313001551 EUDAMEDB-03701313002534 EUDAMEDB-03701313004989 EUDAMEDB-03701313005023 EUDAMEDB-03701313004859 EUDAMEDB-03701313003029 EUDAMEDB-03701313002725 EUDAMEDB-03701313004415 EUDAMEDB-03701313000349 EUDAMEDB-03701313001995 EUDAMEDB-03701313002473 EUDAMEDB-03701313001513 EUDAMEDB-03701313003821 EUDAMEDB-03701313001865 EUDAMEDB-03701313004736 EUDAMEDB-03701313004620 EUDAMEDB-03701313001490 EUDAMEDB-03701313002749 EUDAMEDB-03701313003531 EUDAMEDB-03701313004798 EUDAMEDB-03701313000189 EUDAMEDB-03701313004842 EUDAMEDB-03701313002954 EUDAMEDB-03701313005283 EUDAMEDB-03701313002459 EUDAMEDB-03701313001087 EUDAMEDB-03701313000080 EUDAMEDB-03701313004422 EUDAMEDB-03701313004187 EUDAMEDB-03701313002589 EUDAMEDB-03701313001599 EUDAMEDB-03701313003500 EUDAMEDB-03701313003333 EUDAMEDB-03701313002947 EUDAMED
- 510(k) Number
- K201659 FDA UDI
- FDA Product Code
- NKB FDA UDIFSM FDA UDILXH FDA UDIHWM FDA UDIHXX FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMEDS010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMEDL031199 PROBES AND MIRRORS, REUSABLE - OTHER EUDAMEDP09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMEDL0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMEDP09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMEDL0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDISurgical instrument/implant rack FDA UDIBone-screw internal spinal fixation system hook FDA UDIBone-screw internal spinal fixation system connector FDA UDIInternal spinal fixation procedure kit, reusable FDA UDIBone-screw internal spinal fixation system rod FDA UDISpinal fixation plate, non-bioabsorbable FDA UDIOrthopaedic osteotome FDA UDISurgical screwdriver, reusable FDA UDIBone distraction forceps FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI878.4800 FDA UDI888.4540 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 17 Millimeter FDA UDILength — 30 Millimeter FDA UDIOuter Diameter — 7.5 Millimeter FDA UDILength — 35 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDILength — 60 Millimeter FDA UDILength — 45 Millimeter FDA UDILength — 40 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDILength — 75 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDILength — 9.5 Millimeter FDA UDILength — 7.5 Millimeter FDA UDILength — 11 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDI
Kheiron by S.m.a.i.o — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03701313001483 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (124)
- EUDAMED 6ba0f3b6-a249-4744-928d-ecaf4fcc0aaf 61 fields · synced Sep 18, 2026
- EUDAMED c29a7041-6adb-444d-bb6a-957e6c54bc24 61 fields · synced May 11, 2026
- EUDAMED cd772719-54fe-4d7d-8801-e5cfb0771ba8 61 fields · synced May 11, 2026
- EUDAMED c36919dd-355b-4586-9721-baffe9451fed 61 fields · synced May 16, 2026
- EUDAMED 2e82f570-fef6-437d-82f9-4f4d76d83f50 61 fields · synced May 16, 2026
- EUDAMED cdc93999-01bd-4124-8531-2d31e6c350aa 61 fields · synced May 16, 2026
- EUDAMED b425f2d1-9226-41f5-8693-afae2d90510c 61 fields · synced May 16, 2026
- EUDAMED fe877c3c-79ff-4060-85f0-e62932cdafd8 61 fields · synced May 16, 2026
- EUDAMED 9ad396b0-aff6-43e0-a84a-ae8746840400 61 fields · synced May 16, 2026
- EUDAMED 24c46fab-51d2-4c1a-86b6-b8e722db028d 61 fields · synced May 17, 2026
- EUDAMED 00476234-72e3-429c-8572-77e271790f75 61 fields · synced May 17, 2026
- EUDAMED c9240832-1887-4f99-86f0-ddae669a0ab4 61 fields · synced May 17, 2026
- EUDAMED 9633fb74-3620-428a-9bdd-342628833c70 61 fields · synced May 17, 2026
- EUDAMED 637334fd-5988-41c8-b6bd-c6fba63ce016 61 fields · synced May 17, 2026
- EUDAMED c661038a-2801-45ca-8767-0c2823eb4647 61 fields · synced May 17, 2026
- EUDAMED 55c3213d-5ad6-429c-b616-ccb76b574202 61 fields · synced May 17, 2026
- EUDAMED 8c2adb91-810c-42b3-b9d4-baa9561abaee 61 fields · synced May 17, 2026
- EUDAMED dbb61dd3-0223-498d-a25e-5c819cf39f68 61 fields · synced May 17, 2026
- EUDAMED d84ea4ae-93d4-407e-9ec7-b3ed6889eff6 61 fields · synced May 17, 2026
- EUDAMED 4eeb86fd-ec35-486b-9b47-11041d3a1bb8 61 fields · synced May 17, 2026
- EUDAMED 9c5e3058-6c42-442e-a386-49c1a980fda2 61 fields · synced May 18, 2026
- EUDAMED 92bb8d70-de7c-4595-bf53-45508c469dab 61 fields · synced May 18, 2026
- EUDAMED d3bafa65-96f8-40be-a558-2764fbfac497 61 fields · synced May 18, 2026
- EUDAMED f152cfd3-66bd-4bb5-a212-d56dca9208ee 61 fields · synced May 18, 2026
- EUDAMED cc198cb6-a8e3-4f31-9569-66945cfa5cb6 61 fields · synced May 18, 2026
- EUDAMED 373b3487-db3a-4408-9a61-c9241c6e6c94 61 fields · synced May 18, 2026
- EUDAMED 9b896054-acea-49fa-a8c0-32e00e5ac583 61 fields · synced May 18, 2026
- EUDAMED 0c0d3c50-5472-493c-ba10-3f7c9fd6151f 61 fields · synced May 18, 2026
- EUDAMED a0d07d7f-158b-41b3-b15f-7ca2680fb49c 61 fields · synced May 18, 2026
- EUDAMED 5a2f2253-00a4-4b29-be8f-1f0d3a409188 61 fields · synced May 18, 2026
- FDA UDI c370e570-d2b4-4578-9f0b-a37c2c564ce8 35 fields · synced May 27, 2026
- FDA UDI dcb533e5-930d-48ba-b67d-b0c7f646c330 35 fields · synced May 27, 2026
- FDA UDI 38c926bc-c3cd-4478-b915-8bc7eaabff08 35 fields · synced May 27, 2026
- FDA UDI 1ce537e9-1c5e-4a01-9858-bc19ba605ac3 35 fields · synced May 29, 2026
- FDA UDI 0329772c-184c-4109-baa0-a9e64ecb2080 35 fields · synced May 29, 2026
- FDA UDI 2988604b-7707-4405-84fa-0751dc29cb37 37 fields · synced May 29, 2026
- FDA UDI 1564fbd7-8e1a-4c84-ae1a-1ddff78b737b 35 fields · synced May 29, 2026
- FDA UDI 81696e88-be6c-43ea-8201-d9543971f448 37 fields · synced May 30, 2026
- FDA UDI 6e0ec431-6d4b-40a7-91ea-5c656b6ac887 37 fields · synced May 30, 2026
- FDA UDI c4c926ab-f324-4a02-aa93-caefe619bca6 35 fields · synced May 30, 2026
- FDA UDI c273c1c3-8dde-408f-897c-2532d745f9f1 36 fields · synced May 30, 2026
- FDA UDI 8e6a5d1a-c8df-4901-8c26-4ecf982eb017 35 fields · synced May 30, 2026
- FDA UDI 33bb1802-db16-4629-be36-845de7a9974a 35 fields · synced May 30, 2026
- FDA UDI 7eb7877b-dd7d-4789-a818-4f2d63fe2f7c 36 fields · synced May 30, 2026
- FDA UDI c9665dfa-459f-4586-a68c-300796482f58 37 fields · synced May 30, 2026
- FDA UDI a2b838ec-5df2-4882-ba69-d9a44b376d79 35 fields · synced May 30, 2026
- FDA UDI d7e2b5e8-eae4-4371-9b6e-9bb43699f243 35 fields · synced May 30, 2026
- FDA UDI 65cbb493-b845-4723-8a5a-bffdce4ee137 35 fields · synced May 30, 2026
- FDA UDI 29ae4956-f9f1-4d39-98b6-12c9f159771b 37 fields · synced May 30, 2026
- FDA UDI 41c634e2-872f-452b-86e7-94bcd9c12736 37 fields · synced May 30, 2026
- FDA UDI fac92c98-add2-4724-9fb7-0e082bfbb687 35 fields · synced May 30, 2026
- FDA UDI 1c22a47a-913f-443a-9c4e-4e0d8c99206b 37 fields · synced May 30, 2026
- FDA UDI b27a701b-5a2e-4e17-9bdd-01ca96cc4baa 35 fields · synced May 30, 2026
- FDA UDI a352cba7-1e72-4457-b09e-868ce2af23cf 37 fields · synced May 30, 2026
- FDA UDI e41d373b-02f1-4327-af52-09946ec31553 35 fields · synced May 30, 2026
- FDA UDI 3f5eb59b-03f5-49f6-84a9-c80b15f5cbd2 37 fields · synced May 30, 2026
- FDA UDI d772c9d1-85f3-41f4-9d9f-b866ed34f625 35 fields · synced May 30, 2026
- FDA UDI 1f807b90-1b8b-4bd1-b4d9-91a36e0b644d 33 fields · synced May 30, 2026
- FDA UDI fd0679ae-9b88-49b1-8ff6-611c2b2513f5 37 fields · synced May 30, 2026
- FDA UDI 9be89982-1946-473a-bda7-095b90481254 35 fields · synced May 30, 2026
- FDA UDI e979242b-0974-44f6-805d-dfb30034c2a3 37 fields · synced May 30, 2026
- FDA UDI ca608c78-77d1-45d4-8f8c-81f0070c5141 35 fields · synced May 30, 2026
- FDA UDI 7cfce55d-e8f0-4824-9eae-342b584ebc4b 35 fields · synced May 30, 2026
- FDA UDI 76544811-50ab-433b-9b98-b4c61d5625f1 37 fields · synced May 30, 2026
- FDA UDI edf315dc-a202-4c34-9788-5a640b70b4db 35 fields · synced May 30, 2026
- FDA UDI 88cf6403-6073-40f7-95bd-b08717a76051 35 fields · synced May 30, 2026
- FDA UDI 53f66d27-6593-4c68-aa45-60b89db8dc50 37 fields · synced May 30, 2026
- FDA UDI 663cb362-a3f9-4267-8e73-ea647e9ac21b 35 fields · synced May 30, 2026
- FDA UDI 918daca7-c1e7-47e5-892d-8e429d3a6ed1 35 fields · synced May 30, 2026
- FDA UDI 13450bb0-014b-4b51-b64b-a617102ba05e 35 fields · synced May 30, 2026
- FDA UDI 06403bbc-3e87-46c9-b635-f0d2539fb1be 35 fields · synced May 30, 2026
- FDA UDI ba4ddf61-8993-4742-8018-29d2bbd08b05 35 fields · synced May 30, 2026
- FDA UDI 43c5517c-7385-44dc-884d-e979094421e0 36 fields · synced May 30, 2026
- FDA UDI 8950a7ac-e06b-4e11-84f7-5aaf2dd787aa 35 fields · synced May 30, 2026
- FDA UDI 596c04a0-38f7-48a2-b6f5-60b91fa256e7 35 fields · synced May 30, 2026
- FDA UDI b3e433ab-95b9-4dc9-9aff-8400b2e4dfd0 37 fields · synced May 30, 2026
- EUDAMED ced02ea8-e88a-4d91-ae12-16b6995d2941 61 fields · synced Jun 20, 2026
- EUDAMED 783b6705-3ad1-495e-8064-01628e5ec013 61 fields · synced Jun 20, 2026
- EUDAMED 0772e620-f6b3-4b5f-b574-9a861545da3b 61 fields · synced Jul 8, 2026
- EUDAMED 21fa71a4-74d8-4ad2-a302-b9bac31bc586 61 fields · synced Jul 8, 2026
- EUDAMED 2190b6f0-7723-46f9-b55f-b060e579ee30 61 fields · synced Jul 8, 2026
- EUDAMED 1d702e8b-4368-457f-bde7-45c1bc66abd7 61 fields · synced Jul 8, 2026
- EUDAMED 747f98fe-95c6-4328-ae72-482d47286b4b 61 fields · synced Jul 8, 2026
- EUDAMED b21b12d3-2e25-4b0b-b11f-af288a631d5d 61 fields · synced Jul 9, 2026
- EUDAMED 56d3b2b0-f11d-4777-a884-b68e76d2173b 61 fields · synced Jul 9, 2026
- EUDAMED 7847c63b-0dbe-4775-bca5-51cfb3177b25 61 fields · synced Jul 9, 2026
- EUDAMED 1b295c60-8c13-4e06-848c-62aea1840193 61 fields · synced Jul 9, 2026
- EUDAMED 99896fab-37db-4fd9-ba5c-cdf53c82bd3c 61 fields · synced Jul 9, 2026
- EUDAMED a293f5cf-705b-4cea-b527-668529ed5af6 61 fields · synced Jul 9, 2026
- EUDAMED ff49cf2b-71d3-4dc2-a261-f52694593e5a 61 fields · synced Jul 9, 2026
- EUDAMED 7606592f-c026-441f-a8df-10ce313b69ed 61 fields · synced Jul 10, 2026
- EUDAMED 35cf59ba-ec6b-41b4-8739-3ee2063fe733 61 fields · synced Jul 10, 2026
- EUDAMED b12924fb-28cd-4036-860d-8af5e36dc2ec 61 fields · synced Jul 10, 2026
- EUDAMED eef47aba-f39e-40bf-bdf2-089e8127fc68 61 fields · synced Jul 10, 2026
- EUDAMED d019d5eb-e149-482d-88a8-4fdecd962c9b 61 fields · synced Jul 11, 2026
- EUDAMED 0eff47f3-1269-4eda-a065-9c2f62b9c03e 61 fields · synced Jul 11, 2026
- EUDAMED 0b976dc1-a59a-49a0-b9ad-b76fc2b1e5a4 61 fields · synced Jul 11, 2026
- EUDAMED 1bfeb49a-5477-4c61-891b-65a3aa9a8970 61 fields · synced Jul 11, 2026
- EUDAMED 935b43b5-134a-41df-8b54-df0f92711e1a 61 fields · synced Jul 14, 2026
- EUDAMED e66a5aad-f5ae-449d-9943-7e94a06ba181 61 fields · synced Jul 14, 2026
- EUDAMED 00fbc08d-d422-4a6a-ac93-acb877fdd6aa 61 fields · synced Jul 15, 2026
- EUDAMED 952089f4-e259-442a-b938-9ec3fb1b0f09 61 fields · synced Jul 17, 2026
- EUDAMED fd9e6791-0efa-474a-b3c0-344a175af459 61 fields · synced Jul 17, 2026
- EUDAMED 72accfa1-1014-43a8-9092-ff6d0dac96b8 61 fields · synced Jul 18, 2026
- EUDAMED 01326ac3-f3b2-4d23-896e-bc5681cd7944 61 fields · synced Jul 19, 2026
- EUDAMED 752e0c4a-c68b-4e13-adb3-e40982424d58 61 fields · synced Jul 20, 2026
- EUDAMED 7960d27a-e62d-41ac-9ea8-08bef3ff2b57 61 fields · synced Jul 23, 2026
- EUDAMED d1af531d-a81e-418d-86ee-8d6c2475c9fb 61 fields · synced Jul 23, 2026
- EUDAMED a7c98053-3f57-46db-b755-25f1dfa60a36 61 fields · synced Jul 24, 2026
- EUDAMED 7f6a10d5-aca1-47cc-9c40-6244b7a743b4 61 fields · synced Jul 25, 2026
- EUDAMED 836c7f0d-4347-4a38-99bd-777c85dd5cda 61 fields · synced Jul 27, 2026
- EUDAMED 0049031f-6637-4b58-ba49-093980f51ad9 61 fields · synced Jul 28, 2026
- EUDAMED 3708fa8e-363b-42d3-80b1-21165f5b6026 61 fields · synced Jul 29, 2026
- EUDAMED 4435e16d-c386-4812-8764-fa3510b61f98 61 fields · synced Jul 29, 2026
- EUDAMED b973ac2f-9924-4662-ab8e-9a24147bd79f 61 fields · synced Jul 29, 2026
- EUDAMED 130c6253-d826-439e-885a-f890781c9c54 61 fields · synced Jul 30, 2026
- EUDAMED 571fe983-340e-442d-9fb5-6697ace080b4 61 fields · synced Jul 30, 2026
- EUDAMED 1d74d3d2-94e8-4a46-8372-66b823e39971 61 fields · synced Jul 31, 2026
- EUDAMED ee75dcde-9259-4f21-89f5-e1f66078df71 61 fields · synced Aug 2, 2026
- EUDAMED e9a6a5e8-a165-4ab0-b5cb-1609ab66da3a 61 fields · synced Aug 2, 2026
- EUDAMED 2eb73ca7-07ab-4122-82d9-3a66fba13f7b 61 fields · synced Aug 3, 2026
- EUDAMED 789cb3a5-419f-4fa6-88f8-d969e44d5433 61 fields · synced Aug 3, 2026
- EUDAMED 20c39021-f843-4ce1-8071-fe4b61464771 61 fields · synced Aug 5, 2026
- EUDAMED 32d895ae-84c9-4569-8728-2d41ce3c04c4 61 fields · synced Sep 18, 2026