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Quanlity Control For Urine Analyzer

by Biobase Poct Co., Ltd EUDAMED

Active European Union

Ref BQ-B U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR089）Model BQ-B U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976374752361 Basic UDI-DIDate8 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  • Withdrawn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

Model / Reference
BQ-B U1: 1 × 8 mL, U2: 1 × 8 mL, U3: 1 × 8 mL, U3: 1 × 8 mL（DR089）
Primary DI / UDI-DI
06976374752361
Basic UDI-DI
B-06976374752361
EMDN Code
W0101050207 Urine controls
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045945
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No