Skip to content

Biotime

by Xiamen Biotime Biotechnology Co., Ltd. China EUDAMED

Ref BT2801

EMDN W0102070206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933260208692 Basic UDI-DIDate25 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Vitamin-D Rapid Quantitative Test (Fluorescence Immunoassay)
Model / Reference
BT2801
Primary DI / UDI-DI
06933260208692
Basic UDI-DI
B-06933260208692
EMDN Code
W0102070206 Vitamin d (cholecalciferol)
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012852
Authorised representative
Medunion S.L. ES-AR-000019366

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 9d536662-0012-4bf4-a765-d93af840e4d0 61 fields · synced 22 Oct 2026