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BriteBlade Pro Single-Use Fiber Optic Side Light Mac 3 Strong Curve 040-00-0231U

by Flexicare Medical Limited EUDAMEDGUDID

Active European Union

Ref 040-00-0231U

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055788700746 Basic UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055788700746 UDI-DIDate20 Feb 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Flexicare EUDAMED
BriteBlade Pro Single-Use Fiber Optic Side Light Mac 3 Strong Curve GUDID
Generic Name
Laryngoscope blade, single-use
Device Name
Single Use Laryngoscopes (Fibre Optic, Laryngoscope, Sterile)
Model / Reference
040-00-0231U
Primary DI / UDI-DI
05055788700746
Basic UDI-DI
B-05055788700746
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
Market of Registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laryngoscope blade, single-use

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Sterile
  • 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