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MPV Quantitative Test (Realtime PCR)

by Xiamen Biotime Biotechnology Co., Ltd. China EUDAMED

Ref BT0300301

EMDN W0103010605

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933260208838 Basic UDI-DIDate3 Dec 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
BT0300301
Primary DI / UDI-DI
06933260208838
Basic UDI-DI
B-06933260208838
EMDN Code
W0103010605 Platelets
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012852
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Xiamen Biotime Biotechnology Co., Ltd.

See all devices from Xiamen Biotime Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e3315428-6a08-46f9-8506-74f1eb93ad9c 61 fields · synced 24 Oct 2026