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BLOTrix System 4.0/ BLOTrix Reader S1

by BioSciTec GmbH Germany EUDAMED

Ref B4C/BTR-S1Model BLOTrix System 4/ BLOTrix Reader S1 EMDN W0201069080,W0201069082

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42604972700017N5 Basic UDI-DIDate18 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
BLOTrix System 4.0 (BLOTrix 4.0)
Model / Reference
BLOTrix System 4/ BLOTrix Reader S1, B4C/BTR-S1
Primary DI / UDI-DI
04260497270393
Basic UDI-DI
42604972700017N5
EMDN Code
W0201069080,W0201069082
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
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 (1)

  • EUDAMED c4e98706-2c98-40df-ba92-db5275641a15 61 fields · synced 22 Oct 2026