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M3 Automatic Chemiluminescence Immunoassay Analyzer

by Shanghai Medconn Medical Technology Co., Ltd. China EUDAMED

Model M3 EMDN W0201020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number695441761106R32K Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
M3 Automatic Chemiluminescence Immunoassay Analyzer
Model / Reference
M3
Primary DI / UDI-DI
06954417600152
Basic UDI-DI
695441761106R32K
Direct Marketing DI
06954417600152
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000038658
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Medconn Medical Technology Co., Ltd.

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Properties & raw data

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

Sources (1)

  • EUDAMED 8c859b20-d610-4f42-a8fc-f6c697cde0e4 61 fields · synced 25 Oct 2026