Identity
- Trade Name
- Spreader 10mmx12mm EUDAMED
- Device Name
- Spreader 10mmx12mm EUDAMED
- Model / Reference
- 1509320400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317449844 EUDAMED
- Basic UDI-DI
- B-06941317449844 EUDAMED
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, 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
Spreader 10mmx12mm 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-06941317449844 | 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 e6bd7adb-d682-4a74-977a-aa1fb4b0e17e 61 fields · synced Oct 10, 2026