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Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref GCCr(Ag)-402a

EMDN W0105060303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCCr(Ag)-402aHGDP Basic UDI-DIDate1 Apr 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

Model / Reference
GCCr(Ag)-402a
Primary DI / UDI-DI
D-GCCr(Ag)-402aHGDP, D-GCCr(Ag)-402aRU
Basic UDI-DI
B-GCCr(Ag)-402aHGDP, B-GCCr(Ag)-402aRU
EMDN Code
W0105060303 Cryptococcus
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 421d8db9-2a45-4da2-935d-688c26611b19 61 fields · synced 22 Oct 2026
  • EUDAMED a86959b8-0cfd-4bad-85a1-899befc5a168 61 fields · synced 21 Jul 2026