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Chlamydia Trachomatis Test

by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. China EUDAMED

Ref R16-112

EMDN W0105090101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941571816024 Basic UDI-DIDate1 Jun 2022RegisteredStatusActive

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 24 Oct 2026

Device Name
Chlamydia Trachomatis Test
Model / Reference
R16-112
Primary DI / UDI-DI
06941571816024
Basic UDI-DI
B-06941571816024
EMDN Code
W0105090101 Chlamydia ag - rt & poc
Device Class
Class IVD Annex II List B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000020607
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

See all devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 16ed4cbd-6dbd-4fd8-b61b-c1d21cde5eb8 61 fields · synced 24 Oct 2026