F&P Optiflow TRACE
by Fisher & Paykel Healthcare Limited 3 variants
Ref AA031L
F&P Optiflow TRACE (AA031L) is a Class IIa device made by Fisher & Paykel Healthcare Limited, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI B-09420012453303), active as of 8 Nov 2026.
Active
CE MDD
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/MDD | NumberB-09420012453303 09420012453303 | Date3 Sep 2026 | StatusActive |
Official records
- EUDAMED public site B-09420012453303
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Optiflow Filtered Nasal Interface with CO2 Sampling
- Model / reference
- AA031L
- Primary DI / UDI-DI
- 09420012453303
- Basic UDI-DI
- B-09420012453303
- EMDN code
- R0301020302 High flow therapy nasal cannulas (hfnc)
- Device class
- Class IIa
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- NZ-MF-000002556
- Authorised representative
- FISHER & PAYKEL HEALTHCARE SAS FR-AR-000000294
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