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LineGene Mini Fluorescent Quantitative Detection System

by Hangzhou Bioer Technology Co., Ltd. 3 variants

Ref FQD-16A(EA2H)Model FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)

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 Number697384322FQD001GQ Basic UDI-DI 06973843221229UDI-DIDate28 Aug 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)
Primary DI / UDI-DI
06973843221229
Basic UDI-DI
697384322FQD001GQ
Direct Marketing DI
06973843221229
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019512
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Nucleic acid sample preparation instrument IVD

Other devices from Hangzhou Bioer Technology Co., Ltd.

See all devices from Hangzhou Bioer Technology 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