Skip to content

Fully Automatic Chemistry Analyzer

by Shenzhen Yhlo Biotech Co., Ltd. United States EUDAMED

Ref BC0278Model iBC 900-A

EMDN W0201010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692591270282HP Basic UDI-DIDate7 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Fully Automatic Chemistry Analyzer
Model / Reference
iBC 900-A, BC0278
Primary DI / UDI-DI
06925912721574
Basic UDI-DI
692591270282HP
EMDN Code
W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001137
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Yhlo Biotech Co., Ltd.

See all devices from Shenzhen Yhlo 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 6962a7a8-0ad4-4d05-92f2-29c6686a956a 61 fields · synced 24 Oct 2026