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Access hsTnI Calibrators

by Immunotech SAS France EUDAMED

Ref B52700

EMDN W0102152204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995903AcchsTnICalHV Basic UDI-DIDate11 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
B52700
Primary DI / UDI-DI
15099590693190
Basic UDI-DI
150995903AcchsTnICalHV
EMDN Code
W0102152204 Cardiac marker standards and calibrators
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000011121

Other devices from Immunotech SAS

See all devices from Immunotech SAS →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b278094d-1359-4a50-94c4-560ea8714f21 61 fields · synced 22 Oct 2026