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Auto Chemistry Analyzer

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

Ref BT-200Model BT-120,BT-120P,BT-120M,BT-160,BT-160P,BT-160M,BT-200,BT-200P,BT-200M,BT-240,BT-240P,BT-240M,BT-300,BT-300P,BT-300M,BT-330,BT-330P,BT-330M

EMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517840008LX88 Basic UDI-DIDate13 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-120, BT-120P, BT-120M, BT-160, BT-160P, BT-160M, BT-200, BT-200P, BT-200M, BT-240, BT-240P, BT-240M, BT-300, BT-300P, BT-300M, BT-330, BT-330P, BT-330M
Primary DI / UDI-DI
06975178403615
Basic UDI-DI
697517840008LX88
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 06975178403615|697517840008LX88 61 fields · synced 24 Oct 2026