Identity
- Trade Name
- Sterile Moist Wipes EUDAMED
- Device Name
- Cleansing Wipe EUDAMED
- Model / Reference
- 3~30cmx3~30cm EUDAMEDD5201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05037331009674 EUDAMED
- Basic UDI-DI
- 69228209MDN12042A000037H5 EUDAMED
- Unit of Use DI
- 05037331037882 EUDAMED
- EMDN Code
- M040703 WOUND DEBRIDEMENT PADS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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 Moist Wipes 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 | 69228209MDN12042A000037H5 | 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 cf31e99d-160f-4f7f-9699-08329408d371 61 fields · synced Jun 19, 2026