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Flexicare

by Flexicare Medical Limited 2 variants

Ref 3103842

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-05023323028464 Basic UDI-DI 05023323028464UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05023323028464 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  • Withdrawn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
Mini-Wright GUDID
Generic Name
Expiratory peak flow meter, analogue, reusable
Device Name
PFM and Mouthpieces
Model / Reference
3103842
Primary DI / UDI-DI
05023323028464
Basic UDI-DI
B-05023323028464
FDA Product Code
BZH
EMDN Code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
GMDN Term
Expiratory peak flow meter, analogue, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
868.1860
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
GB-MF-000034163
Authorised representative
Flexicare EU Ops Ltd XI-AR-000048902

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No