Identity
- Trade Name
- Quick Coupling Screwdriver (Torx) (T8) EUDAMED
- Device Name
- Quick Coupling Screwdriver (Torx) (T8) EUDAMED
- Model / Reference
- 1500182600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941317441473 EUDAMED
- Basic UDI-DI
- B-06941317441473 EUDAMED
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Surgical screwdriver, reusable
The Quick Coupling Screwdriver (Torx) (T8) is a medical device designed for drilling and driving screws. This product is manufactured by Changzhou Waston Medical Appliance Co., Ltd, based in Shanghai International Holding Corp. GmbH(Europe), a subsidiary of the Shanghai International Holding Corp. GmbH. The device meets the necessary standards for sterility and patient safety. It is classified as a Legacy medical device and has undergone thorough testing to ensure its effectiveness.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941317441473 | 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 92510cf9-0216-427c-9291-f69b5c10cdec 61 fields · synced Oct 6, 2026