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SensiQuant Direct CBFB/MYH11 MasterMix INV-16E

by Bioclarma S.R.L. EUDAMED

Active European Union

Ref SQTd-046.E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08057723370325 Basic UDI-DIDate22 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
SensiQuant Direct CBFB/MYH11 MasterMix INV-16E
Model / Reference
SQTd-046.E
Primary DI / UDI-DI
08057723370325
Basic UDI-DI
B-08057723370325
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

  • 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