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Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay)

by Shenzhen Genebiohealth Co., Ltd. 2 variants

Ref GC010-24

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975977120072 Basic UDI-DI 06975977120072UDI-DIDate9 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Reprimo and CABIN1 DNA Methylation Detection Kit (Fluorescence PCR Assay)
Model / Reference
GC010-24
Primary DI / UDI-DI
06975977120072
Basic UDI-DI
B-06975977120072
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000046424
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Shenzhen Genebiohealth Co., Ltd.

See all devices from Shenzhen Genebiohealth Co., Ltd. →

Properties

  • 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