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Auto Chemistry Analyzer

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

Ref BT-400LModel BT-200L、BT-210L、BT-220L、BT-240L、BT-260L、BT-280L、BT-300L、BT-310L、BT-320L、BT-340L、BT-360L、BT-380L、BT-400L、BT-410L、BT-420L、BT-440L、BT-460L、BT-480L

EMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517840010LX77 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
BT-200L、BT-210L、BT-220L、BT-240L、BT-260L、BT-280L、BT-300L、BT-310L、BT-320L、BT-340L、BT-360L、BT-380L、BT-400L、BT-410L、BT-420L、BT-440L、BT-460L、BT-480L, BT-400L
Primary DI / UDI-DI
06975178404117
Basic UDI-DI
697517840010LX77
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with 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

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

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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 06975178404117|697517840010LX77 61 fields · synced 23 Oct 2026