F&P Vitera
by Fisher & Paykel Healthcare Limited 7 variants
Part of a family of 12 devices: see the family page
Ref VIT1SU
F&P Vitera (VIT1SU) is a Class IIa device made by Fisher & Paykel Healthcare Limited, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 94200124OSAMSKGS), active as of 8 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number94200124OSAMSKGS 09420012448477 | Date1 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 94200124OSAMSKGS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Mask
- Model / reference
- VIT1SU
- Primary DI / UDI-DI
- 09420012448477
- Basic UDI-DI
- 94200124OSAMSKGS
- EMDN code
- R0301010201 Cpap masks
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NZ-MF-000002556
- Authorised representative
- FISHER & PAYKEL HEALTHCARE SAS FR-AR-000000294
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