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Fluorescence Immunochromatography Analyzer

by Zybio Inc. China EUDAMED

Ref 02-11-03-0003-00Model EXR 100, EXR 110, EXR 120 EMDN W0201020201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628600036ZT Basic UDI-DIDate10 Jan 2023RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Model / Reference
EXR 100, EXR 110, EXR 120, 02-11-03-0003-00
Primary DI / UDI-DI
06941967200192
Basic UDI-DI
69732628600036ZT
Direct Marketing DI
06941967200192
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000003349
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zybio Inc.

See all devices from Zybio Inc. →

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 06941967200192|69732628600036ZT 61 fields · synced 23 Oct 2026