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Adult Nasal Cannula for CO2 Monitoring with 3m Monitoring Line with Male Luer 032-10-108U

by Flexicare Medical Limited

Ref 032-10-108U

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-05055788755852 Basic UDI-DI 05055788755852UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788755852 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  • Withdrawn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 Nasal Cannula for CO2 Monitoring with 3m Monitoring Line with Male Luer
Generic Name
Nasal oxygen cannula, basic
Device Name
Oxygen Therapy
Model / Reference
032-10-108U
Primary DI / UDI-DI
05055788755852
Basic UDI-DI
B-05055788755852
FDA Product Code
CAT
EMDN Code
R0301020301 Oxygen therapy standard nasal cannulas (goggles)
GMDN Term
Nasal oxygen cannula, basic
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5340
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: Nasal oxygen cannula, basic

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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