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Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

by Biobase Diagnostic Technology (Shandong) Co., Ltd. China EUDAMED

Ref 50 Tests/kit（DR1014-1）Model 50 Tests/kit

EMDN W0102030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974969980182 Basic UDI-DIDate8 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
50 Tests/kit, 50 Tests/kit（DR1014-1）
Primary DI / UDI-DI
06974969980182
Basic UDI-DI
B-06974969980182
EMDN Code
W0102030102 Cancer antigen 15-3
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025964
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Diagnostic Technology (Shandong) Co., Ltd.

See all devices from Biobase Diagnostic Technology (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 0c27bd54-5c37-44ff-88b0-3d4b81f48e1c 61 fields · synced 22 Oct 2026