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Cryptococcal Antigen Rapid Test Cassette

by Tianjin Jianbo Biological Co., Ltd. China EUDAMED

Ref C6004

EMDN W0105060303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975344570103 Basic UDI-DIDate7 May 2025RegisteredStatusActive

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
C6004
Primary DI / UDI-DI
06975344570103
Basic UDI-DI
B-06975344570103
EMDN Code
W0105060303 Cryptococcus
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000040307
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Tianjin Jianbo Biological 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 8f466593-8a8f-447d-a748-70d6ff98a7e5 61 fields · synced 22 Oct 2026