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Prealbumin Kit（Turbidimetry Method）

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

Active European Union

Ref 105-000884-00Model 105-000845-00、105-000884-00、105-004607-00、105-001130-00

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number694490400044PA*********TX Basic UDI-DIDate20 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  • Withdrawn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

Device Name
Prealbumin Kit (Turbidimetry Method)、Prealbumin Calibrator
Model / Reference
105-000845-00、105-000884-00、105-004607-00、105-001130-00, 105-000884-00
Primary DI / UDI-DI
06944904025407
Basic UDI-DI
694490400044PA*********TX
EMDN Code
W0102010305 Pre-albumin / transthyretin
Device Class
Class B
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.

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Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No