Skip to content

Chlamydia Trachomatis Antigen Rapid Test (Cassette) (Swab/Urine)

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref GCCHL-502a

EMDN W0105010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCCHL-502aUE Basic UDI-DIDate23 Apr 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

Device Name
Chlamydia Trachomatis Antigen Rapid Test
Model / Reference
GCCHL-502a
Primary DI / UDI-DI
D-GCCHL-502aUE
Basic UDI-DI
B-GCCHL-502aUE
EMDN Code
W0105010107 Chlamydia trachomatis antigen detection
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9ddb19da-5212-41f9-af4a-f3b5d3837d1d 61 fields · synced 22 Oct 2026