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Sterile wound dressing
EUDAMEDClass I (EU MDR)
Ref FA200-9081Model 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etcRef FA200-9086Ref FA200-9179Model 5~25x5~30cm
Identity
- Trade Name
- Sterile wound dressing EUDAMED5.6 x 7.2 cm Sterile wound dressing((adhensive) EUDAMED
- Device Name
- Sterile wound dressing EUDAMEDSterile wound dressing((adhensive)-nonwoven fabric EUDAMED
- Model / Reference
- 5x5cm 7.5cmx7.5cm 10x10cm 10x15cm etc EUDAMEDFA200-9081 EUDAMEDFA200-9086 EUDAMED5~25x5~30cm EUDAMEDFA200-9179 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820990818 EUDAMED06922820990863 EUDAMED06922820991792 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000357Q EUDAMED69228209MDN1204IS0000657Z EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMEDM04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD 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 (3)
- EUDAMED 43e0b5ae-7093-40a9-b6d0-20dc7f5c36ed 61 fields · synced Oct 1, 2026
- EUDAMED f250d0d5-7350-4a3f-b513-4da2f9374ddf 61 fields · synced May 18, 2026
- EUDAMED 460985ec-a417-45d0-86d8-05cca57f420a 61 fields · synced May 19, 2026