Identity
- Trade Name
- Falck Nacl wound wipe EUDAMED
- Device Name
- Cleansing wipe EUDAMED
- Model / Reference
- 10x19cm EUDAMEDF1011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05706636584598 EUDAMED
- Basic UDI-DI
- B-05706636584598 EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Falck Nacl wound wipe by RFX+CARE Manufacturing Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05706636584598 | 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 b1ece33e-bb9c-44e1-bd3a-85577755720f 61 fields · synced Jul 14, 2026