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Flexicare 038-71-985U

by Flexicare Medical Limited

Ref 038-71-985U

Flexicare 038-71-985U is a device classified as Class IIa in the EU and Class II in the US made by Flexicare Medical Limited, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05055931103943) and listed in FDA GUDID since 5 Mar 2024 (UDI-DI 05055931103943), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055931103943 Basic UDI-DI 05055931103943UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055931103943 UDI-DI Date5 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055931103943 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 05055931103943 listed 5 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055931103943
  2. Registered EUDAMED B-05055931103943

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  • Withdrawn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
Pulmonary resuscitator, manual, single-use
Device name
Resus Bags
Model / reference
038-71-985U
Primary DI / UDI-DI
05055931103943
Basic UDI-DI
B-05055931103943
FDA product code
BTM
EMDN code
R03020201 Manually operated pulmonary resuscitators
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5915
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 II

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

Related devices

Category: Pulmonary resuscitator, manual, single-use

Similar devices in this category

Other devices filed under MANUALLY OPERATED PULMONARY RESUSCITATORS.

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)