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F&P OptiPAP Junior OPTIPAPC2937

by Fisher & Paykel Healthcare, Inc.

Ref OPTIPAPC2937

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200124FLEXTCHIST001EE Basic UDI-DI 09420012479143UDI-DIDate26 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420012479143 UDI-DI Date23 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  • Withdrawn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

Trade Name
F&P OptiPAP Junior
Generic Name
CPAP/BPAP chin strap, single-use
Device Name
Chinstrap
Model / Ref / Catalog
OPTIPAPC2937
Primary DI / UDI-DI
09420012479143
Basic UDI-DI
94200124FLEXTCHIST001EE
FDA Product Code
BZO
EMDN Code
R03010280 Oxygen therapy masks and nasal cannulas - accessories
GMDN Term
CPAP/BPAP chin strap, single-use
Device Class
Class I
Regulation Number
868.5975
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Other devices from Fisher & Paykel Healthcare, Inc.

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Properties

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

Other properties (18)

  • 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
  • Serial Number: No