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Automatic Nucleic Acid Purification Instrument

by Hangzhou Bigfish Bio-tech Co., Ltd. China EUDAMED

Ref BFEX-16EModel BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

EMDN W02050106

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697551436BFEX001MK Basic UDI-DIDate28 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Automatic Nucleic Acid Purification Instrument
Model / Reference
BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E, BFEX-16E
Primary DI / UDI-DI
06975514360596
Basic UDI-DI
697551436BFEX001MK
EMDN Code
W02050106 DNA genomic preparation devices
Device Class
Class A
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED fa52e023-e7cf-4a6c-a706-95f0db7d175d 61 fields · synced 24 Oct 2026