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Oxidase Strips

by Oxoid Ltd

Ref MB0266B

Oxidase Strips (MB0266B) is a device classified as Class A in the EU and Class I in the US made by Oxoid Ltd, registered in EUDAMED on 3 Apr 2026 (Basic UDI-DI 5032384OxidaseStripsVH) and listed in FDA GUDID since 4 Dec 2022 (UDI-DI 05032384514359), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5032384OxidaseStripsVH Basic UDI-DI 05032384514359UDI-DIDate3 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05032384514359 UDI-DI Date4 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5032384OxidaseStripsVH registered 3 Apr 2026 Active
  • FDA GUDID UDI-DI 05032384514359 listed 4 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05032384514359
  2. Registered EUDAMED 5032384OxidaseStripsVH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Multiple bacteria species culture isolate identification control IVD, kit
Model / reference
MB0266B
Primary DI / UDI-DI
05032384514359
Basic UDI-DI
5032384OxidaseStripsVH
FDA product code
JTO
EMDN code
W0104080208 Single tests (discs, strips, droppers...)
GMDN term
Multiple bacteria species culture isolate identification control IVD, kit
Device class
Class A EUDAMED
Class I GUDID
Regulation number
866.2660
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
GB-MF-000016914
Authorised representative
Thermo Fisher Diagnostics B.V. NL-AR-000013157

Similar devices in this category

Other devices filed under SINGLE TESTS (DISCS, STRIPS, DROPPERS...).

Other devices from Oxoid Ltd

See all devices from Oxoid Ltd →

Properties

  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)