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IntegraBlade 040-913U

by Flexicare Medical Limited

Ref 040-913U

IntegraBlade 040-913U is a Class I device made by Flexicare Medical Limited, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 5055788700120D05KA) and listed in FDA GUDID since 6 Mar 2024 (UDI-DI 05055788720423), active as of 22 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number5055788700120D05KA Basic UDI-DI 05055788720423UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788720423 UDI-DI Date6 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5055788700120D05KA registered 28 May 2026 Active
  • FDA GUDID UDI-DI 05055788720423 listed 6 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055788720423
  2. Registered EUDAMED 5055788700120D05KA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
IntegraBlade
Generic name
Laryngoscope blade, reusable
Device name
Reusable Laryngoscopes
Model / reference
040-913U
Primary DI / UDI-DI
05055788720423
Basic UDI-DI
5055788700120D05KA
FDA product code
CCW
EMDN code
Z12021003 Laryngoscopes
GMDN term
Laryngoscope blade, reusable
Device class
Class I
Regulation number
868.5540
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 05055788720423: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Laryngoscope blade, reusable

Similar devices in this category

Other devices filed under LARYNGOSCOPES.

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)