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BluBox

by Blusense Diagnostics ApS Denmark EUDAMED

Ref 60BB01Model D6.0

EMDN W0201020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05714132000078 Basic UDI-DIDate21 Oct 2021RegisteredStatusActive
European UnionCE/IVDD NumberB-05714132000078 Basic UDI-DIDate21 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
D6.0, 60BB01
Primary DI / UDI-DI
05714132000078
Basic UDI-DI
B-05714132000078, 5714132ABB01HM
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class IVD General
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
DK-MF-000001418

Other devices from Blusense Diagnostics ApS

Properties & raw data

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

Sources (2)

  • EUDAMED 1a01074c-5a10-47b0-93aa-58b8d7f43cbd 61 fields · synced 22 Oct 2026
  • EUDAMED 05714132000078|5714132ABB01HM 61 fields · synced 19 May 2026