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Sol-Care Silicone Wound Contact Layer
EUDAMEDClass IIb (EU MDR)
Ref SCL1120ERef SCL1140ERef SCL1130E
Identity
- Trade Name
- Sol-Care Silicone Wound Contact Layer EUDAMED
- Device Name
- Silicone Wound Contact Layer EUDAMED
- Model / Reference
- SCL1120E EUDAMEDSCL1140E EUDAMEDSCL1130E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327081748 EUDAMED16942327003269 EUDAMED16942327081762 EUDAMED
- Basic UDI-DI
- 694109403526ER EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Sol-Care Silicone Wound Contact Layer by Winner Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694109403526ER | Class IIb | Active |
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Manufacturer
- Manufacturer
- Winner Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000005692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 75329013-d886-46cb-b7fa-acaa7440678a 61 fields · synced Sep 17, 2026
- EUDAMED 2a1c1c0a-a311-4d7d-a362-9f5a0ef9ad73 61 fields · synced May 18, 2026
- EUDAMED bd27be44-6a34-4b22-bf02-5a8649a3d41f 61 fields · synced May 19, 2026