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croBEE Real-Time PCR System

by GeneProof a.s. 2 variants

Ref CBRT5/96

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number859569630047QT Basic UDI-DI 08595696302450UDI-DIDate17 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
CBRT5/96
Primary DI / UDI-DI
08595696302450
Basic UDI-DI
859569630047QT
Direct Marketing DI
08595696302450
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000002370

From the manufacturer

Manufacturer's product page: Real-time PCR and Extraction Systems

Other devices from GeneProof a.s.

See all devices from GeneProof a.s. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No