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Api® 50 Ch

by Biomerieux SA

Ref 541065

Api® 50 Ch is a device classified as Class B in the EU and Class I in the US made by Biomerieux SA, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 357302BUDI000270T9) and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 03573026588694), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI000270T9 Basic UDI-DI 03573026588694UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026588694 UDI-DI Date10 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI000270T9 registered 26 May 2026 Active
  • FDA GUDID UDI-DI 03573026588694 listed 10 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03573026588694
  2. Registered EUDAMED 357302BUDI000270T9

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  • Withdrawn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
541065 EUDAMED
API® 50 CH GUDID
Primary DI / UDI-DI
03573026588694
Basic UDI-DI
357302BUDI000270T9
FDA product code
JSC
EMDN code
W0104080299 Manual identification - other
GMDN term
Multiple bacteria species culture isolate identification control IVD, kit
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.2350
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
541065
GUDID
API® 50 CH
Device classEUDAMED
Class B
GUDID
Class I

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

Related devices

Category: Multiple bacteria species culture isolate identification control IVD, kit

Similar devices in this category

Other devices filed under MANUAL IDENTIFICATION - OTHER.

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Properties

  • Single use
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)