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SpiroWay

by eResearchTechnology GmbH 2 variants

Ref 892114

SpiroWay (892114) is a diagnostic spirometer (EU MDR Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by eResearchTechnology GmbH, registered in EUDAMED on 28 Jun 2024 (Basic UDI-DI 4057155Z12150101004C9), cleared under FDA 510(k) K213754 on 12 Jun 2023 and listed in FDA GUDID since 22 Jul 2024 (UDI-DI 04057155000801), 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) K213754

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04057155000801 UDI-DI Date22 Jul 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4057155Z12150101004C9 Basic UDI-DI 04057155000801UDI-DIDate28 Jun 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213754 Date12 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4057155Z12150101004C9 registered 28 Jun 2024 Active
  • FDA 510(k) K213754 decided 12 Jun 2023 Active
  • FDA GUDID UDI-DI 04057155000801 listed 22 Jul 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213754
  2. Registered EUDAMED 4057155Z12150101004C9
  3. Listed FDA GUDID 04057155000801

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  • Withdrawn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
Diagnostic spirometer, professional
Device name
iSpiro Ultrasonic Sensor
Model / reference
892114 EUDAMED
SpiroWay GUDID
Primary DI / UDI-DI
04057155000801
Basic UDI-DI
4057155Z12150101004C9
510(k) Number
FDA product code
BZG
EMDN code
Z12150101 Clinical/diagnostic spirometers
GMDN term
Diagnostic spirometer, professional
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
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
892114
GUDID
SpiroWay
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

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

Other devices from eResearchTechnology GmbH

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)