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Chlamydia Trachomatis Antigen Test Cassette

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref SCT-50225Model 25 Tests/Kit, 20 Tests/Kit

EMDN W0105010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566302271 Basic UDI-DIDate12 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
25 Tests/Kit, SCT-50225, 20 Tests/Kit
Primary DI / UDI-DI
06974566302271, 06974566302264
Basic UDI-DI
B-06974566302271, B-06974566302264
EMDN Code
W0105010107 Chlamydia trachomatis antigen detection
Device Class
Class IVD Annex II List B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

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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 (2)

  • EUDAMED 5b61836d-1513-48ff-9e79-87cd824b1c65 61 fields · synced 22 Oct 2026
  • EUDAMED 06974566302264|B-06974566302264 61 fields · synced 18 Jun 2026