Skip to content

CA-331A Automatic Chemistry Analyzer

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref /Model URIT-8031、URIT-8210、URIT-8400、URIT-8460、CA-220、CA-431A、CA-431B、CA-200、CA-641A、CA-641B、CA-641C、CA-150、CA-160、CA-180、CA-351A、CA-351B、CA-351C、CA-431C、URIT-8060、URIT-8030、URIT-8121A、URIT-8131、URIT-8136、CA-331A,etc

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407ICA000002K5 Basic UDI-DIDate14 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Automatic Chemistry Analyzer
Model / Reference
URIT-8031、URIT-8210、URIT-8400、URIT-8460、CA-220、CA-431A、CA-431B、CA-200、CA-641A、CA-641B、CA-641C、CA-150、CA-160、CA-180、CA-351A、CA-351B、CA-351C、CA-431C、URIT-8060、URIT-8030、URIT-8121A、URIT-8131、URIT-8136、CA-331A, etc, /
Primary DI / UDI-DI
06935740722728
Basic UDI-DI
69357407ICA000002K5
Direct Marketing DI
06935740722728
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-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic 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