Skip to content

mLabs® ImmunoMeter

by Micropoint Biotechnologies Co., Ltd. China EUDAMED

Ref m-101 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697470316m-101HS Basic UDI-DIDate26 May 2022RegisteredStatusActive

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  • Withdrawn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
Fluorescent immunoassay analyser IVD, point-of-care
Model / Reference
m-101
Primary DI / UDI-DI
06974703168081
Basic UDI-DI
697470316m-101HS
Direct Marketing DI
06974703168081
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
Market of Registration
Italy

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
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED fa2e5d31-5d68-45c6-b2cd-785f95aec42d 61 fields · synced 22 Oct 2026