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Auto Chemistry Analyzer

by Shenzhen Sinseng Medical Technology Co., Ltd EUDAMED

Active European Union

Ref CAS100Model Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975569870528KK Basic UDI-DIDate26 May 2026RegisteredStatusActive

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  • Withdrawn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
Auto Chemistry Analyzer
Model / Reference
Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400, CAS100
Primary DI / UDI-DI
06975569870521
Basic UDI-DI
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
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • 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