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Thermal cycler

by Hangzhou Bigfish Bio-tech Co., Ltd. 10 variants

Ref FC-384GModel FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T

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 Number697551436ThermalcyclerDH Basic UDI-DI 06975514360862UDI-DIDate6 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  • Withdrawn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

Device Name
Thermal cycler
Model / Reference
FC-96B, FC-96BE, FC-96GE, FC-96D, FC-96G.FC-384G, FC-1536G, FC-48D, FC-48N, FC-48T, FC-384G
Primary DI / UDI-DI
06975514360862
Basic UDI-DI
697551436ThermalcyclerDH
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027212
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Bigfish Bio-tech Co., Ltd.

See all devices from Hangzhou Bigfish Bio-tech 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