Identity
- Trade Name
- RESWELL EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- RVMF001 EUDAMEDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944290679512 EUDAMED
- Basic UDI-DI
- B-06944290679512 EUDAMED
- EMDN Code
- R0301010201 CPAP 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 Mask is a cutting-edge medical device designed for the prevention and treatment of various diseases, particularly in the field of urology. This innovative implantable device features a unique design that combines advanced materials with state-of-the-art technology to provide optimal results.
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-06944290679512 | Class IIa | Unknown |
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Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 940b5220-753c-4d6e-bbb1-9f613a638235 61 fields · synced Jul 3, 2026