Skip to content

cTnI Chemiluminescence Immunoassay Test Kit

by Assure Tech. (Hangzhou) Co., Ltd. EUDAMED

Active European Union

Ref G100A08X

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06952804837075 Basic UDI-DIDate29 Jun 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  • Withdrawn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
cTnI Chemiluminescence Immunoassay Test Kit
Model / Reference
G100A08X
Primary DI / UDI-DI
06952804837075
Basic UDI-DI
B-06952804837075
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000002170
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Assure Tech. (Hangzhou) Co., Ltd.

See all devices from Assure Tech. (Hangzhou) Co., Ltd. →

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