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iSy® Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref P1120.4411Ref P1120.4409Ref P5300.6032Ref P1120.5013Ref P1120.3809Ref P1120.5011
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Implant EUDAMEDiSy® Implant Insertion tool EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- iSy® Implant snap-in EUDAMEDiSy® General instruments EUDAMEDiSy Implant insertion tool, long FDA UDI
- Model / Reference
- P1120.4411 EUDAMEDP1120.4409 EUDAMEDP5300.6032 EUDAMEDFDA UDIP1120.5013 EUDAMEDP1120.3809 EUDAMEDP1120.5011 EUDAMED
- Description
- iSy Implant insertion tool, long FDA UDI
Identifiers
- Catalog Number
- P5300.6032 FDA UDI
- Primary DI / UDI-DI
- 04099797020274 EUDAMED04099797020267 EUDAMED04099797021738 EUDAMED04099797020328 EUDAMED04099797020229 EUDAMED04099797020311 EUDAMEDE219P530060321 FDA UDI
- Basic UDI-DI
- 40997970000604000000000GK EUDAMED40997970008011000000000J5 EUDAMED
- Secondary DI
- E219P112044111 EUDAMEDE219P112044091 EUDAMEDE219P530060321 EUDAMEDE219P112050131 EUDAMEDE219P112038091 EUDAMEDE219P112050111 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMEDZ12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
iSy® Implant by ALTATEC GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970000604000000000GK | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (7)
- EUDAMED d49d6cc5-a30e-49d3-835b-ddb2407ef012 61 fields · synced Jul 31, 2026
- EUDAMED 7b05cec1-2404-40b1-a7bb-1c928b9e2f04 61 fields · synced May 18, 2026
- EUDAMED addcb027-f056-4a7d-949e-7a0e6056b9cf 61 fields · synced May 18, 2026
- EUDAMED 3c45886b-8811-4c80-af2a-d55c4f866468 61 fields · synced May 18, 2026
- FDA UDI 74b1d092-7f7f-4c73-b992-4c6214c26635 35 fields · synced May 30, 2026
- EUDAMED 51b2fa1d-2d4b-468e-9402-13e8b953777f 61 fields · synced Jul 12, 2026
- EUDAMED 9a3af95b-3f5b-4f2d-8b4c-62b145db1021 61 fields · synced Jul 28, 2026