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Flexicare 010-643U

by Flexicare Medical Limited

Ref 010-643U

Flexicare 010-643U 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 18 Aug 2026 (Basic UDI-DI B-05055788762362) and listed in FDA GUDID since 13 Mar 2024 (UDI-DI 05055788762362), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788762362 Basic UDI-DI 05055788762362UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788762362 UDI-DI Date13 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055788762362 registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 05055788762362 listed 13 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055788762362
  2. Registered EUDAMED B-05055788762362

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  • Withdrawn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
Straight/elbow breathing circuit connector, single-use
Device name
Breathing System Components and Accessories
Model / reference
010-643U
Primary DI / UDI-DI
05055788762362
Basic UDI-DI
B-05055788762362
FDA product code
BZA
EMDN code
R028099 Respiratory circuits and mount catheters - accessories not included in other classes
GMDN term
Straight/elbow breathing circuit connector, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5810
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: Straight/elbow breathing circuit connector, single-use

Similar devices in this category

Other devices filed under RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

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)