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Sterile Hydrocolloid dressing
EUDAMEDClass IIa (EU MDR)
Ref FA200-9152Model 7.5×7.5cm, 7×10cm,8×9cm,9×10cm,10×10cm,10×12cm,10×15cm,10×20cm,15×15cm,15×20cm,20×20cm,20×30cm etc,Ref FA200-9146Ref FA200-9144Ref FA200-9150Ref FA200-9141Ref FA200-9142Ref FA200-9148Ref FA200-9143
Identity
- Trade Name
- Sterile Hydrocolloid dressing EUDAMEDSterile Hydrocolloid dressing EUDAMED
- Device Name
- Sterile Hydrocolloid dressing EUDAMED
- Model / Reference
- 7.5×7.5cm, 7×10cm,8×9cm,9×10cm,10×10cm,10×12cm,10×15cm,10×20cm,15×15cm,15×20cm,20×20cm,20×30cm etc, EUDAMEDFA200-9152 EUDAMEDFA200-9146 EUDAMEDFA200-9144 EUDAMEDFA200-9150 EUDAMEDFA200-9141 EUDAMEDFA200-9142 EUDAMEDFA200-9148 EUDAMEDFA200-9143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991525 EUDAMED06922820991464 EUDAMED06922820991440 EUDAMED06922820991501 EUDAMED06922820991419 EUDAMED06922820991426 EUDAMED06922820991488 EUDAMED06922820991433 EUDAMED
- Basic UDI-DI
- 69228209MDN12042A000040GS EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa 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 Hydrocolloid dressing by RFX+CARE Manufacturing Co., Ltd. — Class IIa — 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 | 69228209MDN12042A000040GS | Class IIa | 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 (8)
- EUDAMED 74fef411-84bb-4719-84ab-e3aec2c6fc6b 61 fields · synced Aug 3, 2026
- EUDAMED 75e148a3-aab3-4b5f-8374-c585cdabdf3c 61 fields · synced May 16, 2026
- EUDAMED 830a1860-9777-423d-980f-3ceddc817765 61 fields · synced May 16, 2026
- EUDAMED c3f6af05-a276-4db9-9d36-e8008225a490 61 fields · synced May 17, 2026
- EUDAMED 90327aed-a5c0-45bd-ba59-fb7f666d59e6 61 fields · synced May 17, 2026
- EUDAMED e631298e-f8e2-4b82-94c0-7725173ade7a 61 fields · synced May 18, 2026
- EUDAMED bc74d0a9-f662-40df-8308-1ff81370f01f 61 fields · synced May 18, 2026
- EUDAMED d643beab-9d9b-4645-8005-86b09e0e765f 61 fields · synced May 19, 2026