Identity
- Trade Name
- Distal Guide Bar (320-440) EUDAMED
- Device Name
- Distal Guide Bar (320-440) EUDAMED
- Model / Reference
- 1504801100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317447406 EUDAMED
- Basic UDI-DI
- B-06941317447406 EUDAMED
- EMDN Code
- L098001 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, 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
Distal Guide Bar (320-440) 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-06941317447406 | 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 b50f170c-abf1-49cf-bd7e-f0727a088478 61 fields · synced Oct 9, 2026