Identity
- Trade Name
- RESWELL EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- RVMF001 EUDAMEDS EUDAMEDRVMF001S EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944290679529 EUDAMED
- Basic UDI-DI
- B-06944290679529 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMEDR0301010202 NIV MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Reswell by Beijing Rongrui-Century Science & Technology Co. , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944290679529 | Class IIa | Unknown |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b24f8c87-6e92-4296-9057-9146267d317c 61 fields · synced Oct 6, 2026
- EUDAMED 1b6903bc-ad3a-4651-91f5-52545de600c6 61 fields · synced Aug 1, 2026