Skip to content

Testosterone (TESTO) Reagent Kit (Chemiluminescent Immunoassay)

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref R14014Model 50 Tests/Kit

EMDN W0102050110

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R14014ZN Basic UDI-DIDate14 Jul 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
Testosterone (TESTO) Reagent Kit (Chemiluminescent Immunoassay)
Model / Reference
50 Tests/Kit, R14014
Primary DI / UDI-DI
D-R14014ZN
Basic UDI-DI
B-R14014ZN
EMDN Code
W0102050110 Testosterone (with dehydro and free testosterone)
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

See all devices from Rayto Life and Analytical Sciences Co., Ltd. →

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 f344a259-02d2-4280-9be7-0ffecc540a3a 61 fields · synced 22 Oct 2026