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Orleon

by Eon Meditech Pvt. Ltd India EUDAMED

Ref F7190 , FI150780 , FI1235120 , F7161 , F2142 , FI150870 , F6149S , F3148FTP , F2114BT , F7163 , F31030 , FI152080 , F7170 , F7193 , F2114BW , F3148FSP , F7185 , F5150S , FI1220120 , FI151470 , F1104 , FI1830150, F7183 , F3146US , F7169 , F2141 , FI150770 , FI1220140 , F2113B , F7169 , F2137B , F7165 , F3146UUS , F7165 , FI1230100 , F3115M , F7181 , FI150480, FI150480 , F1106 , F2125 , FI151070 , F5150M , FI1512100, F7177 , FI152070 , F2113 Model PVA Dressings, Suction Tube for Ear-Disposable, Suction Tube for Nose-Disposable , PVA Dressings, Middle Ear Implant, Rhinology, Ear Ventilation Tube, Rhinology , Suction Tube for Ear-Disposable , Suction Tube for Nose-Disposable, Suction Tube for Sinus-Disposable , Middel ear implant

EMDN Q0399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08904428701490 Basic UDI-DIDate11 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Nasal Anatomical Pack Thin (8.0 x 1.0 x 2.0 cm)
Suction Tube for Ear-Disposable (0.7Dia.x80.0)mm
Suction Tube for Nose-Disposable (3.5Dia.x120.0)mm
Ear wick (9.0 Dia. x 15.0 mm)
Fluoroplastic Offset Total Prosthesis
Suction Tube for Ear-Disposable (0.8Dia.x70.0)mm
External Aluminium Splints Small
Internal Nasal Bi-valve Splint - Thin Pediatric
Shepard Blue with Tail
Ear Pack (12.0 Dia. x 15.0 mm)
Epistaxis Balloon Catheter (Intra-Pack)
Suction Tube for Ear-Disposable (2.0Dia.x80.0)mm
Ear wick Fenestrated (9.0 Dia. x 24.0 mm)
Epistaxis Nasal Dressing Pediatric (5.5 x 1.0 x 2.5 cm)
Shepard Blue With Wire
Internal Nasal Bi-valve Splint - Standard Pediatric
Epistaxis Nasal Dressing with String (10.0 x 1.5 x 2.5 cm)
External Thermoplastic Splint Small
Suction Tube for Nose-Disposable (2.0Dia.x120.0)mm
Suction Tube for Ear-Disposable (1.4Dia.x70.0)mm
Tita-prosthesis Vent Tube type Collar Button (ID:1.4mm)
Suction Tube for Sinus-Disposable (3.0Dia.x150.0)mm
Nasal Dressing Thin (8.0 x 1.0 x 2.0 cm)
Silicone Sheets (Thickness: 0.25mm)
Ear wick Fenestrated (9.0 Dia. x 15.0 mm)
Fluoroplastic Offset Partial Prosthesis
Suction Tube for Ear-Disposable (0.7Dia.x70.0)mm
Suction Tube for Nose-Disposable (2.0Dia.x140.0)mm
Mini Shah Blue
Reuter Bobbin blue
Ear Pack (12.0 Dia. x 24.0 mm)
Silicone Sheets (Thickness: 0.13mm)
Ear Pack with string (9.0 Dia. x 15.0 mm)
Suction Tube for Nose-Disposable (3.0Dia.x100.0)mm
T Tube (Silicone) (L: 9mm)
Nasal Pack with String (8.0 x 1.5 x 2.0 cm)
Suction Tube for Ear-Disposable (0.4Dia.x80.0)mm
Tita-prosthesis Vent Tube type Collar Button (ID:1.5mm)
Collar Button (ID:1.14mm)
Suction Tube for Ear-Disposable (1.0Dia.x70.0)mm
External Thermoplastic Splint Medium
Suction Tube for Ear-Disposable (1.2Dia.x100.0)mm
Nasal Pack with String (4.5 x 1.5 x 2.0 cm)
Suction Tube for Ear-Disposable (2.0Dia.x70.0)mm
Mini Shah
Model / Reference
PVA Dressings, F7190, Suction Tube for Ear-Disposable, FI150780, Suction Tube for Nose-Disposable, FI1235120, PVA Dressings, F7161, Middle Ear Implant, F2142, FI150870, Rhinology, F6149S, F3148FTP, Ear Ventilation Tube, F2114BT, F7163, F31030, FI152080, F7170, F7193, F2114BW, F3148FSP, F7185, F5150S, FI1220120, FI151470, F1104, Suction Tube for Sinus-Disposable, FI1830150, F7183, F3146US, F7169, Middel ear implant, F2141, FI150770, FI1220140, F2113B, F2137B, F7165, F3146UUS, FI1230100, F3115M, F7181, FI150480, F1106, F2125, FI151070, F5150M, FI1512100, F7177, FI152070, F2113
Primary DI / UDI-DI
08904428701490, 08904461001335, 08904461001526, 08904461001717, 08904428704132, 08904428705900, 08904428700028, 08904428701179, 08904428700691, 08904428701278, 08904428701247, 08904428708833, 08904461031042, 08904428701520, 08904428700677, 08904428701162, 08904461033947, 08904428704927, 08904461013185, 08904428708888, 08904428700431, 08904428702312, 08904428705382, 08904428705153, 08904428701339, 08904428704149, 08904428705405, 08904428709007, 08904428701728, 08904428706204, 08904428704637, 08904428705276, 08904428700912, 08904461009300, 08904428700417, 08904428705160, 08904428705238, 08904461001359, 08904428704804, 08904428705375, 08904428706280, 08904461001441, 08904428705979, 08904428704774, 08904428704408, 08904461001052, 08904428704941, 08904461047203, 08904428701360, 08904428708826, 08904428704842
Basic UDI-DI
B-08904428701490, B-08904461001335, B-08904461001526, B-08904461001717, B-08904428704132, B-08904428705900, B-08904428700028, B-08904428701179, B-08904428700691, B-08904428701278, B-08904428701247, B-08904428708833, B-08904461031042, B-08904428701520, B-08904428700677, B-08904428701162, B-08904461033947, B-08904428704927, B-08904461013185, B-08904428708888, B-08904428700431, B-08904428702312, B-08904428705382, B-08904428705153, B-08904428701339, B-08904428704149, B-08904428705405, B-08904428709007, B-08904428701728, B-08904428706204, B-08904428704637, B-08904428705276, B-08904428700912, B-08904461009300, B-08904428700417, B-08904428705160, B-08904428705238, B-08904461001359, B-08904428704804, B-08904428705375, B-08904428706280, B-08904461001441, B-08904428705979, B-08904428704774, B-08904428704408, B-08904461001052, B-08904428704941, B-08904461047203, B-08904428701360, B-08904428708826, B-08904428704842
EMDN Code
Q0399, Q030499, P02010101, P02010201, Q030201
Device Class
Class I
Class IIa
Class IIb
Market of Registration
Italy
Germany
Spain
France
Cyprus

Manufacturer details

EUDAMED SRN
IN-MF-000014457
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Eon Meditech Pvt. Ltd

See all devices from Eon Meditech Pvt. Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable NoEUDAMEDYesEUDAMED
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (51)

  • EUDAMED 2407e265-6783-4d8d-ad70-e0b4594a1feb 61 fields · synced 22 Oct 2026
  • EUDAMED 08904461001335|B-08904461001335 61 fields · synced 11 May 2026
  • EUDAMED 08904461001526|B-08904461001526 61 fields · synced 11 May 2026
  • EUDAMED 08904461001717|B-08904461001717 61 fields · synced 11 May 2026
  • EUDAMED 08904428704132|B-08904428704132 61 fields · synced 11 May 2026
  • EUDAMED 08904428705900|B-08904428705900 61 fields · synced 16 May 2026
  • EUDAMED 08904428700028|B-08904428700028 61 fields · synced 16 May 2026
  • EUDAMED 08904428701179|B-08904428701179 61 fields · synced 16 May 2026
  • EUDAMED 08904428700691|B-08904428700691 61 fields · synced 16 May 2026
  • EUDAMED 08904428701278|B-08904428701278 61 fields · synced 16 May 2026
  • EUDAMED 08904428701247|B-08904428701247 61 fields · synced 16 May 2026
  • EUDAMED 08904428708833|B-08904428708833 61 fields · synced 16 May 2026
  • EUDAMED 08904461031042|B-08904461031042 61 fields · synced 16 May 2026
  • EUDAMED 08904428701520|B-08904428701520 61 fields · synced 16 May 2026
  • EUDAMED 08904428700677|B-08904428700677 61 fields · synced 16 May 2026
  • EUDAMED 08904428701162|B-08904428701162 61 fields · synced 16 May 2026
  • EUDAMED 08904461033947|B-08904461033947 61 fields · synced 16 May 2026
  • EUDAMED 08904428704927|B-08904428704927 61 fields · synced 16 May 2026
  • EUDAMED 08904461013185|B-08904461013185 61 fields · synced 16 May 2026
  • EUDAMED 08904428708888|B-08904428708888 61 fields · synced 16 May 2026
  • EUDAMED 08904428700431|B-08904428700431 61 fields · synced 16 May 2026
  • EUDAMED 08904428702312|B-08904428702312 61 fields · synced 16 May 2026
  • EUDAMED 08904428705382|B-08904428705382 61 fields · synced 16 May 2026
  • EUDAMED 08904428705153|B-08904428705153 61 fields · synced 16 May 2026
  • EUDAMED 08904428701339|B-08904428701339 61 fields · synced 17 May 2026
  • EUDAMED 08904428704149|B-08904428704149 61 fields · synced 17 May 2026
  • EUDAMED 08904428705405|B-08904428705405 61 fields · synced 17 May 2026
  • EUDAMED 08904428709007|B-08904428709007 61 fields · synced 17 May 2026
  • EUDAMED 08904428701728|B-08904428701728 61 fields · synced 17 May 2026
  • EUDAMED 08904428706204|B-08904428706204 61 fields · synced 17 May 2026
  • EUDAMED 08904428704637|B-08904428704637 61 fields · synced 17 May 2026
  • EUDAMED 08904428705276|B-08904428705276 61 fields · synced 17 May 2026
  • EUDAMED 08904428700912|B-08904428700912 61 fields · synced 17 May 2026
  • EUDAMED 08904461009300|B-08904461009300 61 fields · synced 17 May 2026
  • EUDAMED 08904428700417|B-08904428700417 61 fields · synced 17 May 2026
  • EUDAMED 08904428705160|B-08904428705160 61 fields · synced 17 May 2026
  • EUDAMED 08904428705238|B-08904428705238 61 fields · synced 17 May 2026
  • EUDAMED 08904461001359|B-08904461001359 61 fields · synced 17 May 2026
  • EUDAMED 08904428704804|B-08904428704804 61 fields · synced 17 May 2026
  • EUDAMED 08904428705375|B-08904428705375 61 fields · synced 17 May 2026
  • EUDAMED 08904428706280|B-08904428706280 61 fields · synced 17 May 2026
  • EUDAMED 08904461001441|B-08904461001441 61 fields · synced 17 May 2026
  • EUDAMED 08904428705979|B-08904428705979 61 fields · synced 17 May 2026
  • EUDAMED 08904428704774|B-08904428704774 61 fields · synced 17 May 2026
  • EUDAMED 08904428704408|B-08904428704408 61 fields · synced 17 May 2026
  • EUDAMED 08904461001052|B-08904461001052 61 fields · synced 17 May 2026
  • EUDAMED 08904428704941|B-08904428704941 61 fields · synced 17 May 2026
  • EUDAMED 08904461047203|B-08904461047203 61 fields · synced 17 May 2026
  • EUDAMED 08904428701360|B-08904428701360 61 fields · synced 17 May 2026
  • EUDAMED 08904428708826|B-08904428708826 61 fields · synced 17 May 2026
  • EUDAMED 08904428704842|B-08904428704842 61 fields · synced 17 May 2026