Identity
- Trade Name
- Medifoam Scargel EUDAMED
- Model / Reference
- MCG12N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806129680855 EUDAMED
- Basic UDI-DI
- 880612960001F4 EUDAMED
- EMDN Code
- M04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
Classification
- Device Class
- Class I 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
Medifoam Scargel by Genewel Co., Ltd. — Class I — 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 | 880612960001F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Genewel Co., Ltd.
- EUDAMED SRN
- KR-MF-000009205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 47077125-7cf4-46aa-8530-10b198f5f27d 61 fields · synced Jun 19, 2026