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Automatic Biochip Analyzer

by Jiangsu Sunlant Bioengineering Co., Ltd. China EUDAMED

Ref XPCA

EMDN W0201030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697479552XPCAXE Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
XPCA
Primary DI / UDI-DI
06974795529975
Basic UDI-DI
697479552XPCAXE
Direct Marketing DI
06974795529975
EMDN Code
W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025940
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Jiangsu Sunlant Bioengineering Co., Ltd.

See all devices from Jiangsu Sunlant Bioengineering Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 2fdb5a64-a6b9-4aa1-b2bd-65c9dc430b87 61 fields · synced 22 Oct 2026