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MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)

by Genobio Pharmaceutical Co., Ltd. EUDAMED

Active European Union

Ref MCRLFA-01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970514081342 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)
Model / Reference
MCRLFA-01
Primary DI / UDI-DI
06970514081342
Basic UDI-DI
B-06970514081342
EMDN Code
W0105011799 Bacteriology immunoassay - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000027997
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Genobio Pharmaceutical Co., Ltd.

See all devices from Genobio Pharmaceutical Co., Ltd. →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No