Identity
- Trade Name
- evercare EUDAMED
- Device Name
- Silicone Foam Dressing EUDAMED
- Model / Reference
- ESF200200N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06940610131647 EUDAMED
- Basic UDI-DI
- 69406101SF00018N EUDAMED
- Unit of Use DI
- 06940610131630 EUDAMED
- EMDN Code
- M04040602 POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden 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
evercare 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 | 69406101SF00018N | 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 18f8957e-326d-4a07-b3e2-5d5e93faae0d 61 fields · synced Jun 19, 2026