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Airzone 3130045

by Clement Clarke International Limited

Ref 3130045

Airzone 3130045 is a device classified as Class I in the EU and Class II in the US made by Clement Clarke International Limited, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05023323001214) and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323001214), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05023323001214 Basic UDI-DI 05023323001214UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05023323001214 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05023323001214 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 05023323001214 listed 7 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05023323001214
  2. Registered EUDAMED B-05023323001214

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  • Withdrawn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
Airzone GUDID
Generic name
Expiratory peak flow meter, analogue, reusable
Device name
PFM and Mouthpieces
Model / Ref / Catalog
3130045
Primary DI / UDI-DI
05023323001214
Basic UDI-DI
B-05023323001214
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 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: Expiratory peak flow meter, analogue, reusable

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)