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Cleansing Wipe
EUDAMEDClass IIa (EU MDR)
Ref FA200-9166Model 3~30cmx3~30cmRef FA200-9137Ref FA200-9140Ref FA200-9134Ref FA200-9136Ref FS-620Ref P21201031Ref FA200-9131Ref P21201035Ref FA200-9130Ref FA200-9132
Identity
- Trade Name
- Cleansing Wipe EUDAMED
- Device Name
- Cleansing Wipe EUDAMED
- Model / Reference
- 3~30cmx3~30cm EUDAMEDFA200-9166 EUDAMEDFA200-9137 EUDAMEDFA200-9140 EUDAMEDFA200-9134 EUDAMEDFA200-9136 EUDAMEDFS-620 EUDAMEDP21201031 EUDAMEDFA200-9131 EUDAMEDP21201035 EUDAMEDFA200-9130 EUDAMEDFA200-9132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991662 EUDAMED06922820991372 EUDAMED06922820991402 EUDAMED06922820991341 EUDAMED06922820991365 EUDAMED06922820908547 EUDAMED06922820920518 EUDAMED06922820991310 EUDAMED06922820909209 EUDAMED06922820991303 EUDAMED06922820991327 EUDAMED
- Basic UDI-DI
- 69228209MDN12042A000037H5 EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMEDM040703 WOUND DEBRIDEMENT PADS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDGermany EUDAMEDSweden 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
Cleansing Wipe 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 (11)
- EUDAMED 42469458-6c38-40df-8208-413652fe4bb5 61 fields · synced Aug 4, 2026
- EUDAMED b139eeac-4092-4610-bced-9160d4eaa9e4 61 fields · synced May 16, 2026
- EUDAMED 7b93798e-5e5f-42fa-a28b-a39c7873b45f 61 fields · synced May 16, 2026
- EUDAMED 016dbc2f-7541-4c8a-9ec9-9113760f248f 61 fields · synced May 16, 2026
- EUDAMED a9ed66c1-bc1c-49ab-a394-5123362d4d82 61 fields · synced May 17, 2026
- EUDAMED 4623ce2a-0547-4dd8-9834-75c86ff68971 61 fields · synced May 17, 2026
- EUDAMED 6666db9e-ba88-43a5-8b24-3c2c54b9020f 61 fields · synced May 17, 2026
- EUDAMED e63e902c-ba44-484a-8f3b-7551dce29f0f 61 fields · synced May 17, 2026
- EUDAMED e845fefd-d9a6-4eff-b6f9-19d4111f717e 61 fields · synced May 18, 2026
- EUDAMED 01578750-b29b-4cb2-83b1-85324f4ad560 61 fields · synced May 18, 2026
- EUDAMED 1c01854f-b846-4540-94d5-77602dc37c10 61 fields · synced May 19, 2026