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Automatic Biochemistry Analyzer

by Taizhou Zecen Biotech Co., Ltd. China EUDAMED

Ref NEO-380

EMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697420115YQ003E5 Basic UDI-DIDate19 Nov 2025RegisteredStatusActive

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
NEO-380
Primary DI / UDI-DI
06976868801032
Basic UDI-DI
697420115YQ003E5
Direct Marketing DI
06976868801032
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000050486
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Taizhou Zecen Biotech Co., Ltd.

See all devices from Taizhou Zecen Biotech 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 54258edb-701f-4436-943a-b87b75b5e2e1 61 fields · synced 22 Oct 2026