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Antea
EUDAMEDClass IIb (EU MDR)
Ref 3301152Model ANTEA Ti6Al4V FIXED RADIAL HEAD TiNbN COATED DIAM. 19 H 1mm
Identity
- Trade Name
- ANTEA EUDAMED
- Model / Reference
- ANTEA Ti6Al4V FIXED RADIAL HEAD TiNbN COATED DIAM. 19 H 1mm EUDAMED3301152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053617182869 EUDAMED
- Basic UDI-DI
- B-08053617182869 EUDAMED
- EMDN Code
- P090204 ELBOW PROSTHESES RADIAL COMPONENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Antea by Adler Ortho S.p.A — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053617182869 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adler Ortho S.p.A
- EUDAMED SRN
- IT-MF-000010164
Sources (1)
- EUDAMED 0643d0d8-641e-4618-9c02-1703d1b335d6 61 fields · synced Aug 3, 2026