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mLabs® Smart

by Micropoint Biotechnologies Co., Ltd. China EUDAMED

Ref m-20 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697470316m-20LF Basic UDI-DIDate27 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  • Withdrawn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-20
Primary DI / UDI-DI
06974703168098
Basic UDI-DI
697470316m-20LF
Direct Marketing DI
06974703168098
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 d380ff9b-008b-4cf1-a451-45db18cb3a53 61 fields · synced 22 Oct 2026