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Avoximeter

by Accriva Diagnostics, Inc. 3 variants

Ref C100B

Avoximeter (C100B) is a device classified as IVD General (EU), Class II (US) made by Accriva Diagnostics, Inc., registered in EUDAMED on 12 Nov 2025 (Basic UDI-DI B-10711234160022), cleared under FDA 510(k) K922075 on 4 Nov 1992 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 10711234160022), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

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

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K922075

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/IVDD EUDAMED NumberB-10711234160022 Basic UDI-DI 10711234160022UDI-DIDate12 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10711234160022 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK922075 Date4 Nov 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10711234160022 registered 12 Nov 2025 Active
  • FDA 510(k) K922075 decided 4 Nov 1992 Active
  • FDA GUDID UDI-DI 10711234160022 listed 22 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

3 recalls · FDA

    • Completed Z-0279-2025 FDA Class II initiated 27 Sep 2024

    Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

  • 2 recalls, same reason

    • Terminated Z-1238-2008 FDA Unclassified (pre-2012) initiated 13 Feb 2008
    • Terminated Z-1237-2008 FDA Unclassified (pre-2012) initiated 13 Feb 2008

    Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

Timeline

6 dated events

  1. Cleared FDA 510(k) K922075
  2. Recall initiated FDA recalls Z-1238-2008
  3. Recall initiated FDA recalls Z-1237-2008
  4. Listed FDA GUDID 10711234160022
  5. Recall initiated FDA recalls Z-0279-2025
  6. Registered EUDAMED B-10711234160022

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Avoximeter EUDAMED
Avoximeter Whole Blood Oximeter GUDID
Generic name
Multiple blood gas analyte IVD, reagent
Model / Ref / Catalog
C100B
Primary DI / UDI-DI
10711234160022
Basic UDI-DI
B-10711234160022
510(k) Number
FDA product code
DQA
EMDN code
W0201040185 Blood gas analysers - consumables
GMDN term
Multiple blood gas analyte IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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
US-MF-000009902
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under BLOOD GAS ANALYSERS - CONSUMABLES.

Other devices from Accriva Diagnostics, Inc.

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Properties

  • Single use
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)