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Sol-Care CMC Gelling Fiber Dressing, Extra Strength
EUDAMEDClass IIb (EU MDR)
Ref FCD1130E
Identity
- Trade Name
- Sol-Care CMC Gelling Fiber Dressing, Extra Strength EUDAMED
- Device Name
- CMC Gelling Fiber Dressing EUDAMED
- Model / Reference
- FCD1130E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942327081168 EUDAMED
- Basic UDI-DI
- 694109403524EM EUDAMED
- EMDN Code
- M040404 CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES 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 CMC Gelling Fiber Dressing, Extra Strength 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 | 694109403524EM | 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 (1)
- EUDAMED 11a9c6a0-3119-4956-8788-9fcbc5a7dc56 61 fields · synced Jul 15, 2026