Skip to content

AFP Calibrators

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref 105-004283-00Model 105-004214-00 、105-004241-00、105-004283-00

EMDN W0102152205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000225E Basic UDI-DIDate19 Aug 2023RegisteredStatusActive

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
Alpha-fetoprotein (CLIA)、AFP Calibrators
Model / Reference
105-004214-00 、105-004241-00、105-004283-00, 105-004283-00
Primary DI / UDI-DI
06944904048246
Basic UDI-DI
69449040AB74000225E
EMDN Code
W0102152205 Tumour marker standards and calibrators
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 6e6b402f-48fc-4b7a-b87c-39f45d5ec010 61 fields · synced 24 Oct 2026