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Mini Wright 3104050

by Clement Clarke International Limited

Ref 3104050

Mini Wright 3104050 is a peak flow meter (EU MDD Class I; FDA Class II; FDA product code BZH, Meter, Peak Flow, Spirometry) made by Clement Clarke International Limited, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05023323040503), cleared under FDA 510(k) K952713 on 29 Mar 1996 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323040503), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K952713

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05023323040503 Basic UDI-DI 05023323040503UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05023323040503 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK952713 Date29 Mar 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05023323040503 registered 17 Aug 2026 Active
  • FDA 510(k) K952713 decided 29 Mar 1996 Active
  • FDA GUDID UDI-DI 05023323040503 listed 7 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K952713
  2. Listed FDA GUDID 05023323040503
  3. Registered EUDAMED B-05023323040503

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Flexicare EUDAMED
Mini Wright GUDID
Generic name
Peak flow meter, manual
Device name
PFM and Mouthpieces
Model / Ref / Catalog
3104050
Primary DI / UDI-DI
05023323040503
Basic UDI-DI
B-05023323040503
510(k) Number
FDA product code
BZH
EMDN code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
GMDN term
Peak flow meter, manual
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.1860
EU registration type
Legacy device (under a directive)
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

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Peak flow meter, manual

Cleared under the same submission (K952713)

Similar devices in this category

Other devices filed under INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS.

Other devices from Clement Clarke International Limited

See all devices from Clement Clarke International Limited →

Properties

  • Administering medicine
  • Measuring function
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)