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qLabs® FIB Test Strips

by Micropoint Biotechnologies Co., Ltd. China EUDAMED

Ref QS-18 Pro

EMDN W0103020899

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974703160269 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
QS-18 Pro
Primary DI / UDI-DI
06974703160269
Basic UDI-DI
B-06974703160269
EMDN Code
W0103020899 Haemostasis rt & poc - other
Device Class
Class IVD General
Market of Registration
France

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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a4f5a5f2-4387-4f77-98b2-2087718a6eeb 61 fields · synced 22 Oct 2026