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BritePro Omni 040-06-2015U

by Flexicare Medical Limited

Ref 040-06-2015U

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

CE MDD

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/MDD EUDAMED NumberB-05055788795650 Basic UDI-DI 05055788795650UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788795650 UDI-DI Date19 Jun 2026ListedStatusListed GUDID: 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Flexicare EUDAMED
BritePro Omni GUDID
Generic Name
Laryngoscope blade, single-use
Device Name
Single Use Laryngoscopes (Fibre Optic, Laryngoscope, Sterile)
Model / Reference
040-06-2015U
Primary DI / UDI-DI
05055788795650
Basic UDI-DI
B-05055788795650
FDA Product Code
CCW
EMDN Code
R9002 Laryngoscope blades, single-use
GMDN Term
Laryngoscope blade, single-use
Device Class
Class I
Regulation Number
868.5540
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

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

Other properties (18)

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