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Adult Medium Concentration Mask with Head Strap and 2.1m Oxygen Tubing 032-10-002U

by Flexicare Medical Limited

Ref 032-10-002U

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788759607 Basic UDI-DI 05055788759607UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788759607 UDI-DI Date28 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Adult Medium Concentration Mask with Head Strap and 2.1m Oxygen Tubing
Generic Name
Rebreathing oxygen face mask
Device Name
Oxygen Therapy
Model / Reference
032-10-002U
Primary DI / UDI-DI
05055788759607
Basic UDI-DI
B-05055788759607
FDA Product Code
BYG
EMDN Code
R03010201 Air/oxygen masks
GMDN Term
Rebreathing oxygen face mask
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5580
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Rebreathing oxygen face mask

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No