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Gonorrhea + Chlamydia Antigen Combo Test Cassette

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

Ref SGC-5222Model 2 Tests/Kit EMDN W0105090199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566302318 Basic UDI-DIDate12 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
2 Tests/Kit, SGC-5222
Primary DI / UDI-DI
06974566302318
Basic UDI-DI
B-06974566302318
EMDN Code
W0105090199 Bacteriology - rt & poc - other
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 (1)

  • EUDAMED fca7a8e0-88b5-4d40-abbd-3009944018db 61 fields · synced 24 Oct 2026