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Rotationsflowgeber

by eResearchTechnology GmbH

Ref 1413xxModel AM3

Rotationsflowgeber (1413xx) is an expiratory peak flow meter (EU MDR Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by eResearchTechnology GmbH, registered in EUDAMED on 4 Apr 2023 (Basic UDI-DI 4057155Z12150102001CA), cleared under FDA 510(k) K133722 on 8 May 2014 (2 earlier submissions) and listed in FDA GUDID since 22 Jul 2019 (UDI-DI 04057155000337), active as of 22 Oct 2026.

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

CE MDR 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) K133722

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4057155Z12150102001CA Basic UDI-DI 04057155000337UDI-DIDate4 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number04057155000337 UDI-DI Date22 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133722 Date8 May 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4057155Z12150102001CA registered 4 Apr 2023 Active
  • FDA 510(k) K133722 decided 8 May 2014 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04057155000337 listed 22 Jul 2019 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K090486
  2. Cleared FDA 510(k) K092890
  3. Cleared FDA 510(k) K133722
  4. Listed FDA GUDID 04057155000337
  5. Registered EUDAMED 4057155Z12150102001CA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Expiratory peak flow meter, digital
Model / reference
AM3 EUDAMED
1413xx EUDAMED
Rotationsflowgeber GUDID
Primary DI / UDI-DI
04057155000337
Basic UDI-DI
4057155Z12150102001CA
510(k) Number
FDA product code
BZG
EMDN code
Z12150102 Peak flow spirometers
GMDN term
Expiratory peak flow meter, digital
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AM3
1413xx
GUDID
Rotationsflowgeber
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
DE-MF-000008015

Related devices

Category: Expiratory peak flow meter, digital

Similar devices in this category

Other devices filed under PEAK FLOW SPIROMETERS.

Other devices from eResearchTechnology GmbH

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Properties

  • Single use
  • Lot / batch number
Other properties (23, all answered No)