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F&P OptiPAP Junior

by Fisher & Paykel Healthcare Limited 3 variants

Ref OPTIPAPB3445

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200124FLEXTBONMID001LL Basic UDI-DI 09420012479266UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420012479266 UDI-DI Date20 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Neonatal CPAP nasal mask holder
Device Name
Bonnet
Model / Ref / Catalog
OPTIPAPB3445
Primary DI / UDI-DI
09420012479266
Basic UDI-DI
94200124FLEXTBONMID001LL
FDA Product Code
SGR
EMDN Code
R03010280 Oxygen therapy masks and nasal cannulas - accessories
GMDN Term
Neonatal CPAP nasal mask holder
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.5895
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NZ-MF-000002556
Authorised representative
FISHER & PAYKEL HEALTHCARE SAS FR-AR-000000294

Other devices from Fisher & Paykel Healthcare, Ltd.

See all devices from Fisher & Paykel Healthcare, Ltd. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No