Identity
- Trade Name
- 1.8 Threaded Drill Guide (Ø1.8) EUDAMED
- Device Name
- 1.8 Threaded Drill Guide (Ø1.8) EUDAMED
- Model / Reference
- 1502001400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317441008 EUDAMED
- Basic UDI-DI
- B-06941317441008 EUDAMED
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, 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
1.8 Threaded Drill Guide (Ø1.8) by Changzhou Waston Medical Appliance Co., Ltd — Class I — 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-06941317441008 | 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 (1)
- EUDAMED 25b339bb-5485-4ffa-a900-f356f9b53d0c 61 fields · synced Aug 1, 2026