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CARBA 5 In 1 Rapid Test Cassette

by Healgen Scientific Limited Liability Company EUDAMED

Active European Union

Ref GCCRE-T1402a

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCCRE-T1402aHGFX Basic UDI-DIDate31 Mar 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  • Withdrawn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

Model / Reference
GCCRE-T1402a
Primary DI / UDI-DI
D-GCCRE-T1402aHGFX
Basic UDI-DI
B-GCCRE-T1402aHGFX
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
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

Show properties
  • Animal Tissues
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No