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Squamous Cell Carcinoma Antigen (SCC) Assay Kit (Chemiluminescent Immunoassay)

by Sichuan Orienter Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref DD0401Model 2×50 test/box Calibrator:0.5mL×2

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970522642382 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
2×50 test/box Calibrator:0.5mL×2, DD0401
Primary DI / UDI-DI
06970522642382
Basic UDI-DI
B-06970522642382
EMDN Code
W0102030116 Squamous cell carcinoma antigen
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003026
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Sichuan Orienter Biotechnology Co., Ltd.

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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