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DNA Collection Card

by Tianjin Geneally Biotechnology Co., Ltd China EUDAMED

Ref Model A, IndicatingModel 1.Model A, Indicating 2.Model B, Dried Blood Spot(DBS) 3.Model C, DNA Storage

EMDN W05019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697770622DCC001D3 Basic UDI-DIDate8 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
DNA Collection Card
Model / Reference
1.Model A, Indicating 2.Model B, Dried Blood Spot(DBS) 3.Model C, DNA Storage, Model A, Indicating
Primary DI / UDI-DI
06977706221005
Basic UDI-DI
697770622DCC001D3
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000043699
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Geneally Biotechnology Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED ccaf3355-039c-495b-962a-e1d5f72c61fb 61 fields · synced 22 Oct 2026