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BLOTrix System 5.3/ BLOTrix Reader S1

by BioSciTec GmbH Germany EUDAMED

Ref B5-5.3/BTR-S1, b55btrs1Model BLOTrix System 5/ BLOTrix Reader S1 EMDN W0201069080,W0201069082

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42604972700020MS Basic UDI-DIDate3 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BLOTrix System 5.3/ BLOTrix Reader S1
BLOTrix System 5/ BLOTrix Reader S1
Device Name
BLOTrix System 5
Model / Reference
BLOTrix System 5/ BLOTrix Reader S1, B5-5.3/BTR-S1, b55btrs1
Primary DI / UDI-DI
04260497270508, 04260497270621
Basic UDI-DI
42604972700020MS, 42604972700022MW
EMDN Code
W0201069080,W0201069082, W0201069080
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007888

From the manufacturer

Manufacturer's product page: BLOTrix Reader C -Series

Other devices from BioSciTec GmbH

See all devices from BioSciTec GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing YesEUDAMEDNoEUDAMED
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 7ad6b0d4-df79-4dbf-a65a-f0a47126d9d3 61 fields · synced 22 Oct 2026
  • EUDAMED 04260497270621|42604972700022MW 61 fields · synced 26 Jul 2026