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Automatic Electrochemiluminescence Immunoassay Analyzer

by Jiangsu Sunlant Bioengineering Co., Ltd. China EUDAMED

Ref SECA, SEBA EMDN W0201020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697479552SECAUL Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
SECA, SEBA
Primary DI / UDI-DI
06974795529999, 06974795529982
Basic UDI-DI
697479552SECAUL, 697479552SEBAUH
Direct Marketing DI
06974795529999
06974795529982
EMDN Code
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 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 (2)

  • EUDAMED ebb98489-e598-496b-9c08-5a3d4b18b8df 61 fields · synced 24 Oct 2026
  • EUDAMED 06974795529982|697479552SEBAUH 61 fields · synced 18 May 2026