Identity
- Device Name
- SCAR RELIEF HYDROGEL DRESSING EUDAMED
- Model / Reference
- P-66-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951641900041 EUDAMED
- Basic UDI-DI
- 69516419P662D EUDAMED
- EMDN Code
- M04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Scar Relief Hydrogel Dressing by Changsha Hairun Biotechnology Co., Ltd. — Class IIa — 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 | 69516419P662D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changsha Hairun Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018236
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 616e493b-c1f3-4f1f-b474-8753c2d89c63 61 fields · synced Jul 16, 2026