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In-Check 3109750

by Clement Clarke International Limited

Ref 3109750

In-Check 3109750 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-05023323000408), cleared under FDA 510(k) K980960 on 10 Jun 1998 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323000408), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K980960

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05023323000408 Basic UDI-DI 05023323000408UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05023323000408 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK980960 Date10 Jun 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05023323000408 registered 17 Aug 2026 Active
  • FDA 510(k) K980960 decided 10 Jun 1998 Active
  • FDA GUDID UDI-DI 05023323000408 listed 7 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K980960
  2. Listed FDA GUDID 05023323000408
  3. Registered EUDAMED B-05023323000408

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  • Withdrawn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
In-Check GUDID
Generic name
Incentive spirometer
Device name
PFM and Mouthpieces
Model / Ref / Catalog
3109750
Primary DI / UDI-DI
05023323000408
Basic UDI-DI
B-05023323000408
510(k) Number
FDA product code
BZH
EMDN code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
GMDN term
Incentive spirometer
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: Incentive spirometer

Cleared under the same submission (K980960)

and 3 more cleared under K980960

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)