Identity
- Device Name
- Silicone Wound Contact Dressing EUDAMED
- Model / Reference
- SC100100S-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940610129095 EUDAMED
- Basic UDI-DI
- 69406101SC00027P EUDAMED
- Unit of Use DI
- 06940610129040 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Silicone Wound Contact Dressing by Huizhou Foryou Medical Devices 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 | 69406101SC00027P | Class IIb | Active |
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Manufacturer
- Manufacturer
- Huizhou Foryou Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007344
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8162e966-8b71-42d2-8213-49e7b550f8de 61 fields · synced Jun 18, 2026