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HEV IgG Control

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

Ref 105-045976-00Model 105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-00

EMDN W0105080802

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000425L Basic UDI-DIDate11 Jun 2025RegisteredStatusActive

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
Hepatitis E Virus IgG Antibody (CLIA), HEV IgG Control
Model / Reference
105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-00
Primary DI / UDI-DI
06903053074865
Basic UDI-DI
69449040AB74000425L
Direct Marketing DI
06903053074865
EMDN Code
W0105080802 Hepatitis virus controls - inf.imm.
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: 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 b5378f6b-7305-41e6-91ac-f6af247747cd 61 fields · synced 24 Oct 2026