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MatchX

by Immucor GTI Diagnostics, Inc

Ref 888628

MatchX (888628) is a device classified as Class C (EU), Unclassified (US) made by Immucor GTI Diagnostics, Inc, registered in EUDAMED on 10 Aug 2026 (Basic UDI-DI 08500795050VAT), listed under FDA premarket submission BK241067 and listed in FDA GUDID since 30 Sep 2025 (UDI-DI 10850079505312), active as of 8 Nov 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK241067

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08500795050VAT Basic UDI-DI 10850079505312UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850079505312 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK241067 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08500795050VAT registered 10 Aug 2026 Active
  • FDA premarket submission BK241067 Active
  • FDA GUDID UDI-DI 10850079505312 listed 30 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10850079505312
  2. Registered EUDAMED 08500795050VAT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
888628
Primary DI / UDI-DI
10850079505312 EUDAMED
10888234500858 GUDID
Basic UDI-DI
08500795050VAT
Direct marketing DI
10850079505312
FDA product code
MZI
EMDN code
W02029092 Various hematology / histology / cytology instruments - IVD medical device software
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class C EUDAMED
U GUDID
Special device type
Software
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
Primary DI / UDI-DIEUDAMED
10850079505312
GUDID
10888234500858
Device classEUDAMED
Class C
GUDID
U

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10850079505312; FDA GUDID lists 10888234500858), so their flags are not compared. Device class is stated on each registry's own scale: Class C in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000020921
Authorised representative
IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083

Similar devices in this category

Other devices filed under VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE.

Other devices from Immucor GTI Diagnostics, Inc

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Properties

  • Professional testing
  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)