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PIVKA-II Control

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

Ref 105-031983-00Model 105-029894-00, 105-029895-00,105-029896-00,105-031983-00,105-031984-00,105-031981-00,105-031982-00,105-031987-00,105-031988-00 ,105-031985-00,105-031986-00 EMDN W0102152005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB74000305D Basic UDI-DIDate8 Apr 2024RegisteredStatusActive

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  • Withdrawn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 · synced 25 Oct 2026

Device Name
PIVKA-II (CLIA)，PIVKA-II Calibrators，PIVKA-II Control
Model / Reference
105-029894-00, 105-029895-00, 105-029896-00, 105-031983-00, 105-031984-00, 105-031981-00, 105-031982-00, 105-031987-00, 105-031988-00, 105-031985-00, 105-031986-00
Primary DI / UDI-DI
06903053068796
Basic UDI-DI
69449040AB74000305D
Direct Marketing DI
06903053068796
EMDN Code
W0102152005 Tumour marker controls
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 608cc91b-3ff4-42dd-a2b3-3e41b99aa1f7 61 fields · synced 25 Oct 2026