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5 x 5cm Sterile wound dressing((adhensive)
EUDAMEDClass I (EU MDR)
Ref FA200-9178Model 5~25x5~30cm
Identity
- Trade Name
- 5 x 5cm Sterile wound dressing((adhensive) EUDAMED
- Device Name
- Sterile wound dressing((adhensive)-nonwoven fabric EUDAMED
- Model / Reference
- 5~25x5~30cm EUDAMEDFA200-9178 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991785 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000657Z EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER 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
5 x 5cm Sterile wound dressing((adhensive) 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 | 69228209MDN1204IS0000657Z | 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 ac0b55e0-1426-438c-ba79-efdf1cb23d2c 61 fields · synced Jul 13, 2026