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Auto Chemistry Analyzer

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

Ref BT-800LModel : BT-600L, BT-610L, BT-620L, BT-630L, BT-800L, BT-810L, BT-820L, BT-830L

EMDN W0201010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517840009LX8D 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 24 Oct 2026

Model / Reference
: BT-600L, BT-610L, BT-620L, BT-630L, BT-800L, BT-810L, BT-820L, BT-830L
Primary DI / UDI-DI
06975178404216
Basic UDI-DI
697517840009LX8D
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
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 06975178404216|697517840009LX8D 61 fields · synced 24 Oct 2026