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Q-Smart

by PROTIA Inc. South Korea EUDAMED

Ref MQSM2901

EMDN W0201020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880944648QSM29RD Basic UDI-DIDate4 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Q-Smart
Model / Reference
MQSM2901
Primary DI / UDI-DI
08809446480306
Basic UDI-DI
880944648QSM29RD
Direct Marketing DI
08809446480306
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000026040
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from PROTIA Inc.

See all devices from PROTIA Inc. →

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 65e461f1-73d9-4acb-bec2-415053862d15 61 fields · synced 24 Oct 2026