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Sample Preservation Solution

by Ustar Biotechnologies (Hangzhou) Ltd. China EUDAMED

Ref U400014-100 EMDN W05019099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697349224U4000142A000FE Basic UDI-DIDate31 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sample Preservation Solution
Model / Reference
U400014-100
Primary DI / UDI-DI
06973492241708
Basic UDI-DI
697349224U4000142A000FE
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000014615
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ustar Biotechnologies (Hangzhou) Ltd.

See all devices from Ustar Biotechnologies (Hangzhou) 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 fc0cb2c2-fe8d-41d9-b367-f278b82fd03d 61 fields · synced 24 Oct 2026