← Back to catalogue
Sterile wound dressing
EUDAMEDClass I (EU MDR)
Ref FA200-9080Model 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etcRef FA200-9085Ref FA200-9089Ref FA200-9090Ref FA200-9096Ref FA200-9093Ref FA200-9083Ref FA200-9097Ref FA200-9078
Identity
- Trade Name
- Sterile wound dressing EUDAMED
- Device Name
- Sterile wound dressing EUDAMED
- Model / Reference
- 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc EUDAMEDFA200-9080 EUDAMEDFA200-9085 EUDAMEDFA200-9089 EUDAMEDFA200-9090 EUDAMEDFA200-9096 EUDAMEDFA200-9093 EUDAMEDFA200-9083 EUDAMEDFA200-9097 EUDAMEDFA200-9078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820990801 EUDAMED06922820990856 EUDAMED06922820990894 EUDAMED06922820990900 EUDAMED06922820990962 EUDAMED06922820990931 EUDAMED06922820990832 EUDAMED06922820990979 EUDAMED06922820990788 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000357Q EUDAMED
- Unit of Use DI
- 86922820990838 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (9)
- EUDAMED 8a7125b7-a3b2-431a-8bc9-5c4cc8b5d896 61 fields · synced Jul 18, 2026
- EUDAMED bf7b8898-1951-41c0-83b4-e018305c7a45 61 fields · synced May 17, 2026
- EUDAMED b9dfa513-783f-423c-acd5-6a4946aced5f 61 fields · synced May 18, 2026
- EUDAMED e6180a73-2ea7-4c50-b9e1-c1d7296443aa 61 fields · synced May 18, 2026
- EUDAMED d124666e-ce28-4eda-9c72-3dd5fd9f65f7 61 fields · synced May 18, 2026
- EUDAMED 88625079-8abb-4aa2-8a5b-3e35a8f2b887 61 fields · synced May 18, 2026
- EUDAMED 379b3767-73d6-4853-9f12-3c755f2c9bb1 61 fields · synced May 18, 2026
- EUDAMED ff1924e3-b26c-4f11-ae44-5d0bfd1d92f6 61 fields · synced May 18, 2026
- EUDAMED acf0de68-a262-429e-afc6-a6e6120c8e8f 61 fields · synced May 19, 2026