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Sterile Hydrocolloid dressing
EUDAMEDClass IIa (EU MDR)
Ref FA200-9145Model 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,
Identity
- Trade Name
- Sterile 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, EUDAMEDFA200-9145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991457 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 (1)
- EUDAMED 520643f9-4622-449f-95d3-29fe00614425 61 fields · synced Jun 19, 2026