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Testosterone (TESTO) Reagent Kit (Chemiluminescent Immunoassay)

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

Active European Union

Ref R14012Model 100 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-R14012ZJ Basic UDI-DIDate14 Jul 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  • Withdrawn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

Device Name
Testosterone (TESTO) Reagent Kit (Chemiluminescent Immunoassay)
Model / Reference
100 Tests/Kit, R14012
Primary DI / UDI-DI
D-R14012ZJ
Basic UDI-DI
B-R14012ZJ
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

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Properties

Show properties
  • 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