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Flexicare 038-53-535U

by Flexicare Medical Limited

Ref 038-53-535U

Flexicare 038-53-535U is a device classified as Class IIa in the EU and Class I in the US made by Flexicare Medical Limited, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05055931117445) and listed in FDA GUDID since 13 Mar 2024 (UDI-DI 05055931117445), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055931117445 Basic UDI-DI 05055931117445UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055931117445 UDI-DI Date13 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055931117445 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 05055931117445 listed 13 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055931117445
  2. Registered EUDAMED B-05055931117445

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  • Withdrawn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
Flexicare
Generic name
Cardiopulmonary resuscitation mask, single-use
Device name
Resuscitation Circuits
Model / reference
038-53-535U
Primary DI / UDI-DI
05055931117445
Basic UDI-DI
B-05055931117445
FDA product code
BYG
EMDN code
R03010199 Ventilation masks - other
GMDN term
Cardiopulmonary resuscitation mask, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5580
EU registration type
Legacy device (under a directive)
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

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiopulmonary resuscitation mask, single-use

Similar devices in this category

Other devices filed under VENTILATION MASKS - OTHER.

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 (20, all answered No)