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Cryptococcal Antigen Rapid Test Kit (Colloidal gold method)

by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED

Ref CR019

EMDN W0105060399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473307840 Basic UDI-DIDate1 Sep 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 22 Oct 2026

Model / Reference
CR019
Primary DI / UDI-DI
06974473307840
Basic UDI-DI
B-06974473307840
EMDN Code
W0105060399 Mycology immunoassays - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing Synthgene Medical Technology Co., Ltd.

See all devices from Nanjing Synthgene Medical Technology 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 99d5b0f4-687a-4fb9-9407-d3477e8943c9 61 fields · synced 22 Oct 2026