Identity
- Trade Name
- Trephine(D4.5 EUDAMED
- Device Name
- Trephine(D4.5 EUDAMED
- Model / Reference
- 1505310200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317442739 EUDAMED
- Basic UDI-DI
- B-06941317442739 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(D4.5 by Changzhou Waston Medical Appliance Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone trephine, reusable.
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- DENTECH — Dentech Corp. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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-06941317442739 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 (1)
- EUDAMED 8d454093-8334-414f-8675-d0a299ea9de4 61 fields · synced Jul 11, 2026