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BIOSYNEX Strep A

by BIOSYNEX Swiss SA Switzerland EUDAMED

Ref 1030005 EMDN W0105090103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-03700531700277 Basic UDI-DIDate30 Apr 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  • Withdrawn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 24 Oct 2026

Model / Reference
1030005
Primary DI / UDI-DI
03700531700277
Basic UDI-DI
B-03700531700277
EMDN Code
W0105090103 Strep. a - rt & poc
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 62979386-60ef-4896-84a0-1811365b63c6 61 fields · synced 24 Oct 2026