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qLabs® eStation

by Micropoint Biotechnologies Co., Ltd. China EUDAMED

Ref MBI91-1

EMDN W0201010280

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697470316MBI91-1J7 Basic UDI-DIDate13 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Accessory Software & Printer
Model / Reference
MBI91-1
Primary DI / UDI-DI
06974703168142
Basic UDI-DI
697470316MBI91-1J7
Direct Marketing DI
06974703168142
EMDN Code
W0201010280 Limited panel chemistry analysers - hardware accessories
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000007991
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Micropoint Biotechnologies Co., Ltd.

See all devices from Micropoint Biotechnologies Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 66459c01-aad1-4919-ae9c-af562b847bef 61 fields · synced 22 Oct 2026