Identity
- Trade Name
- Trephine(D6.5 EUDAMEDTrephine EUDAMED
- Device Name
- Trephine(D6.5 EUDAMEDTrephine EUDAMED
- Model / Reference
- 1505320200 EUDAMED1509320100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317442746 EUDAMED06941317449813 EUDAMED
- Basic UDI-DI
- B-06941317442746 EUDAMEDB-06941317449813 EUDAMED
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Bone trephine, reusable
Trephine(D6.5 by Changzhou Waston Medical Appliance Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06941317442746 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Waston Medical Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000004851
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f836c925-1318-40b7-9725-848a327555b5 61 fields · synced Jul 23, 2026
- EUDAMED 4a8bbc62-f56c-4d64-9dfe-9465dc40461f 61 fields · synced May 19, 2026