Skip to content

GeneMind

by GeneMind Biosciences Co., Ltd. China EUDAMED

Ref R000018Model PET 10mL,50 tubes/box；GL 10mL,50 tubes/box

EMDN W050101010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697496858OE05UN Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

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
Cell-Free DNA Collection Tube
Model / Reference
PET 10mL, 50 tubes/box；GL 10mL, 50 tubes/box, R000018
Primary DI / UDI-DI
16974968584241
Basic UDI-DI
697496858OE05UN
Direct Marketing DI
16974968584241
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000025785
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from GeneMind Biosciences Co., Ltd.

See all devices from GeneMind Biosciences 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 16974968584241|697496858OE05UN 61 fields · synced 24 Oct 2026