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HEA 1.2 BeadChip Kit

by BioArray Solutions Ltd EUDAMED

Active European Union

Ref 800-10202-08

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850081948735 Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
HEA 1.2 BeadChip Kit (Slide CE)
Model / Reference
800-10202-08
Primary DI / UDI-DI
00850081948735
Basic UDI-DI
B-00850081948735
EMDN Code
W01030499 Tissue typing reagents - other
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000022068
Authorised representative
IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083

Other devices from Bioarray Solutions Ltd

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No