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BIOSYNEX Troponin BSS

by BIOSYNEX Swiss SA Switzerland EUDAMED

Ref SW50002 EMDN W01021306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03700531700567 Basic UDI-DIDate6 May 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
SW50002
Primary DI / UDI-DI
03700531700567
Basic UDI-DI
B-03700531700567
EMDN Code
W01021306 Troponin i/t
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CH-MF-000024717
Authorised representative
BIOSYNEX FR-AR-000014076

Other devices from BIOSYNEX Swiss SA

See all devices from BIOSYNEX Swiss SA →

Properties & raw data

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

Sources (1)

  • EUDAMED c9fef01f-525c-40c0-91c5-5fbeeb9113cb 61 fields · synced 22 Oct 2026