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SensiQuant CBFB/MYH11 Standard

by Bioclarma S.R.L. Italy EUDAMED

Ref STD-046, STD-046.A

EMDN W01060211

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08057723370332 Basic UDI-DIDate22 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
SensiQuant CBFB/MYH11 Standard
SensiQuant CBFB/MYH11 Standard INV-16A
Model / Reference
STD-046, STD-046.A
Primary DI / UDI-DI
08057723370332, 08057723370349
Basic UDI-DI
B-08057723370332, B-08057723370349
EMDN Code
W01060211 Inv (16)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000030384

Other devices from Bioclarma S.R.L.

See all devices from Bioclarma S.R.L. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 86adf1aa-9df2-4ae0-b824-3a40313a199d 61 fields · synced 22 Oct 2026
  • EUDAMED 08057723370349|B-08057723370349 61 fields · synced 18 May 2026