Silicone Wound Contact Layer
by Winner Medical Co., Ltd. United States EUDAMED
Ref 19721297Model Silicone wound contact layer, One-side adhesive (Two-layer), Type I / Silicone wound contact layer, Two-side adhesive, Type III
EMDN M04040701
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694109403526ER | Date24 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Silicone Wound Contact Layer
- Model / Reference
- Silicone wound contact layer, One-side adhesive (Two-layer), Type I / Silicone wound contact layer, Two-side adhesive, Type III, 19721297
- Primary DI / UDI-DI
- 16942327007892
- Basic UDI-DI
- 694109403526ER
- EMDN Code
- M04040701 Silicone dressings, non-combined
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005692
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Winner Medical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- 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
Sources (1)
- EUDAMED 16942327007892|694109403526ER