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WiZARD 320
EUDAMEDClass IIa (EU MDR)
Ref SM08002Model WiZARD 320
by Wellell Inc.
Identity
- Trade Name
- WiZARD 320 EUDAMED
- Device Name
- Full Face Mask EUDAMED
- Model / Reference
- WiZARD 320 EUDAMEDSM08002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893348392 EUDAMED
- Basic UDI-DI
- B-04719893348392 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
WiZARD 320 by Wellell Inc. — 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-04719893348392 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wellell Inc.
- EUDAMED SRN
- TW-MF-000009159
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (1)
- EUDAMED 2bcd4c48-c002-4a43-8921-cc22aeecc49b 61 fields · synced Jul 18, 2026