Identity
- Trade Name
- Template 8x40 EUDAMED
- Device Name
- Template 8x40 EUDAMED
- Model / Reference
- 1509321000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317449905 EUDAMED
- Basic UDI-DI
- B-06941317449905 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER 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
Template 8x40 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-06941317449905 | 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 2d1ee170-ec9b-4ef7-ab74-d5d2792a50f4 61 fields · synced Oct 6, 2026