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Fully Automated Nucleic Acid Extraction and Real-time PCR System

by Hybribio Medtech Device Co., Ltd

Ref HB-IEX96Q

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697515792HBIEX96QBU Basic UDI-DI 06975157920263UDI-DIDate28 Aug 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  • Withdrawn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
HB-IEX96Q
Primary DI / UDI-DI
06975157920263
Basic UDI-DI
697515792HBIEX96QBU
Direct Marketing DI
06975157920263
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023113
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Hybribio Medtech Device Co., Ltd

See all devices from Hybribio Medtech Device Co., Ltd →

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