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qLabs® PT-INR Test Strips

by Micropoint Biotechnologies Co., Ltd. China EUDAMED

Ref QS-1-12 EMDN W0102160801

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974703160214 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
QS-1-12
Primary DI / UDI-DI
06974703160214
Basic UDI-DI
B-06974703160214
EMDN Code
W0102160801 Controls immunochem - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007991
Authorised representative
Obelis s.a. BE-AR-000000106

From the manufacturer

Manufacturer's product page: qLabs® Test Strips

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
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a086ccce-64a8-4cf6-b375-b4ab10b823ca 61 fields · synced 24 Oct 2026