Identity
- Device Name
- Silicone Gel Scar Dressing EUDAMED
- Model / Reference
- SCARV16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940610133467 EUDAMED
- Basic UDI-DI
- 69406101SS0001D5 EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Category: Scar-management dressing, reusable
Silicone Gel Scar Dressing by Huizhou Foryou Medical Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69406101SS0001D5 | Class I | 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 bfe6959a-8bc2-4709-ada1-56e6d3e89b9d 61 fields · synced Jun 20, 2026