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Semi-Auto Chemistry Analyzer

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

Ref ES-100PModel ES-105、ES-104、ES-103、ES-102、ES-101C、ES-100P、ES-100C、ES-90C、ES-90

EMDN W0201010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517840002LZ7E Basic UDI-DIDate14 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
ES-105、ES-104、ES-103、ES-102、ES-101C、ES-100P、ES-100C、ES-90C、ES-90, ES-100P
Primary DI / UDI-DI
06975178400188
Basic UDI-DI
697517840002LZ7E
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

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

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 06975178400188|697517840002LZ7E 61 fields · synced 23 Oct 2026