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Semi-auto Chemistry Analyzer

by Shenzhen Sinseng Medical Technology Co., Ltd EUDAMED

Active European Union

Ref CAS60, CAS70, S120proModel CAS60 CAS70 CAS80 CAS90, Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697556987SSCAS45 Basic UDI-DIDate20 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Device Name
Semi-auto Chemistry Analyzer
Auto Chemistry Analyzer
Model / Reference
CAS60 CAS70 CAS80 CAS90, CAS60, CAS70, Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400, S120pro
Primary DI / UDI-DI
06975569870002, 06975569870033, 06975569870163
Basic UDI-DI
697556987SSCAS45, 6975569870528KK
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000024231
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Shenzhen Sinseng Medical Technology Co., Ltd

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Properties

  • Professional Testing
  • Surgical Instrument
  • New Device NoEUDAMEDYesEUDAMED

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