Identity
- Trade Name
- Hinge Pin EUDAMED
- Device Name
- Hinge Pin EUDAMED
- Model / Reference
- Φ10×48mm EUDAMED8602-1115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735177590 EUDAMED
- Basic UDI-DI
- B-06943735177590 EUDAMED
- EMDN Code
- P09098099 KNEE PROSTHESES - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Hinge Pin by Beijing AK Medical Co., Ltd. — 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-06943735177590 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing AK Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018814
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 93d004ff-9524-4d76-ad8e-fbbcbf0f4202 61 fields · synced Oct 6, 2026