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Total Bile Acid (TBA) Test Kit (Enzymatic Cycling)

by Biobase Biodustry(Shandong) Co., Ltd. China EUDAMED

Ref R1:90mL×1 R2:30mL×1（708）

EMDN W01010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06971674863120 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
R1:90mL×1 R2:30mL×1（708）
Primary DI / UDI-DI
06971674863120
Basic UDI-DI
B-06971674863120
EMDN Code
W01010202 Bile acids
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

See all devices from Biobase Biodustry(Shandong) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED a453b649-d65b-47be-9e77-481338e321f0 61 fields · synced 22 Oct 2026