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BriteBlade Pro Evo Single-Use Fiber Optic Mac 3 040-753U

by Flexicare Medical Limited

Ref 040-753U

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5055788700120B01JQ Basic UDI-DI 05055788722588UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788722588 UDI-DI Date22 Oct 2020ListedStatusListed GUDID: not 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
BriteBlade Pro Evo Single-Use Fiber Optic Mac 3
Generic Name
Laryngoscope blade, single-use
Device Name
Single Use Laryngoscopes
Model / Reference
040-753U
Primary DI / UDI-DI
05055788722588
Basic UDI-DI
5055788700120B01JQ
FDA Product Code
CCW
EMDN Code
Z12021003 Laryngoscopes
GMDN Term
Laryngoscope blade, single-use
Device Class
Class I
Regulation Number
868.5540
EU market of registration
Northern Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
No
GUDID
Yes

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No