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Sterile wound dressing
EUDAMEDClass I (EU MDR)
Ref FA200-9084Model 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc
Identity
- Trade Name
- Sterile wound dressing EUDAMED
- Device Name
- Sterile wound dressing EUDAMED
- Model / Reference
- 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc EUDAMEDFA200-9084 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820990849 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000357Q EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Sterile wound dressing by RFX+CARE Manufacturing 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 | 69228209MDN1204IS0000357Q | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED b17e3949-7885-4655-b023-6a732ef8a83b 61 fields · synced Jun 18, 2026