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Genedian

by Hangzhou DIAN Biotechnology Co., Ltd. 9 variants

Ref P131-02025

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 Number69342445RA001JL Basic UDI-DI 06934244550004UDI-DIDate22 Sep 2022RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
Cell Preservation Solution
Model / Reference
P131-02025
Primary DI / UDI-DI
06934244550004
Basic UDI-DI
69342445RA001JL
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000007252
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou DIAN Biotechnology Co., Ltd.

See all devices from Hangzhou DIAN Biotechnology 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