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IDH1 R132H [IHC132]

by Biocare Medical EUDAMED

Active European Union

Ref OPAI3253T60

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00847627028860 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
OPAI3253T60
Primary DI / UDI-DI
00847627028860
Basic UDI-DI
B-00847627028860
EMDN Code
W0102039099 Tumour markers - other
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
US-MF-000034581
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties

Show properties
  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No