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DNA/RNA Extraction/Purification Kit

by Hangzhou Bigfish Bio-tech Co., Ltd. 58 variants

Ref BFMP01RModel 1T、32T、96T、100T、256T

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 Number697551436BFMP001NK Basic UDI-DI 06975514360909UDI-DIDate28 Feb 2023RegisteredStatusActive

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  • Withdrawn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
DNA/RNA Extraction/Purification Kit
Model / Reference
1T、32T、96T、100T、256T, BFMP01R
Primary DI / UDI-DI
06975514360909
Basic UDI-DI
697551436BFMP001NK
EMDN Code
W0104080601, W0104080602, W0104080699
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

  • Reagent
  • Professional Testing

Other properties (9)

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