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Incentive Spirometer (Flow rate)

by Besmed Health Business Corp.

Ref TB-93100

Incentive Spirometer (Flow rate) (TB-93100) is an incentive spirometer (EU MDR Class IIa; EU MDR Class I; FDA Class II; FDA product code BWF, Spirometer, Therapeutic (Incentive)) made by Besmed Health Business Corp., registered in EUDAMED on 9 Dec 2021 (Basic UDI-DI B-TB-93100ZW), cleared under FDA 510(k) K133873 on 4 Apr 2014 and listed in FDA GUDID since 6 Sep 2016 (UDI-DI D-TB-93100ZW), active as of 22 Oct 2026.

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

CE MDR 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) K133873

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/MDR EUDAMED NumberB-TB-93100ZW Basic UDI-DI Date9 Dec 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-TB-93100ZW Basic UDI-DI Date9 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-TB-93100ZW UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133873 Date4 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-TB-93100ZW registered 9 Dec 2021 Active· +1 more in the status table
  • FDA 510(k) K133873 decided 4 Apr 2014 Active
  • FDA GUDID UDI-DI D-TB-93100ZW listed 6 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133873
  2. Listed FDA GUDID D-TB-93100ZW
  3. Registered EUDAMED B-TB-93100ZW

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Incentive Spirometer (Flow rate) EUDAMED
Incentive SPIROMETER,600/900/1200ml GUDID
Generic name
Incentive spirometer
Model / reference
TB-93100
Primary DI / UDI-DI
D-TB-93100ZW, 04716770931005
Basic UDI-DI
B-TB-93100ZW, 4716770TB09300HA
Direct marketing DI
04716770931005
510(k) Number
FDA product code
BWF
EMDN code
Z12150102 Peak flow spirometers
GMDN term
Incentive spirometer
Device class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation number
868.5690
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany
Cyprus
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa and Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

Related devices

Category: Expiratory peak flow meter, digital

Similar devices in this category

Other devices filed under PEAK FLOW SPIROMETERS.

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties

  • Reprocessed single-use device NoEUDAMEDYesEUDAMED
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)