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Auto Chemiluminescence Immunoassay Analyzer

by E-LAB Biological Science & Technology Co., Ltd. China EUDAMED

Ref IA151Model IA120, IA121, IA122, IA150, IA151, IA152, IA180, IA181, IA182, IA1200, IA201, IA202

EMDN W0201020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517840007M766 Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
IA120, IA121, IA122, IA150, IA151, IA152, IA180, IA181, IA182, IA1200, IA201, IA202
Primary DI / UDI-DI
06975178404469
Basic UDI-DI
697517840007M766
EMDN Code
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000020119
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from E-LAB Biological Science & Technology Co., Ltd.

See all devices from E-LAB Biological Science & Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 06975178404469|697517840007M766 61 fields · synced 23 Oct 2026