Skip to content

Semi-automatic Biochemistry Analyzer

by Seamaty Diagnostic Co., Ltd. EUDAMED

Active European Union

Ref AWGBZDFXY-0001Model SMT-70

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975347780028F2 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
SMT-70, AWGBZDFXY-0001
Primary DI / UDI-DI
06975347780028
Basic UDI-DI
6975347780028F2
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000033945
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Seamaty Diagnostic Co., Ltd.

See all devices from Seamaty Diagnostic Co., Ltd. →

Properties

  • 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