Identity
- Trade Name
- Drill Bit EUDAMED
- Device Name
- Shaft, Φ6.5 EUDAMED
- Model / Reference
- Shaft, Φ6.5 EUDAMED14301301E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931720408453 EUDAMED
- Basic UDI-DI
- B-06931720408453 EUDAMED
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Drill Bit by Stryker Trauson (Changzhou) Medical Technology Co., Ltd. — Class IIa — 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-06931720408453 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005689
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ef29dbff-ce74-46dd-abbd-5d16a85b5f5a 61 fields · synced Sep 30, 2026