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MQ-8000 Glycated Hemoglobin Analyzer

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

Model MQ-8000 EMDN W02020699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69544176150180YJ Basic UDI-DIDate20 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  • Withdrawn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 24 Oct 2026

Device Name
MQ-8000 Glycated Hemoglobin Analyzer
Model / Reference
MQ-8000
Primary DI / UDI-DI
06954417600121, 06954417600077
Basic UDI-DI
69544176150180YJ
Direct Marketing DI
06954417600121
06954417600077
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
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 (2)

  • EUDAMED f8a4edbd-11ef-4b20-9f77-eda67fea2f2b 61 fields · synced 24 Oct 2026
  • EUDAMED 06954417600077|69544176150180YJ 61 fields · synced 19 May 2026