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CA-430B Automatic Chemistry Analyzer

EUDAMED

Class A (EU MDR)

Ref /Model URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C

by URIT Medical Electronic Co., Ltd.

Identity

Trade Name
CA-430B Automatic Chemistry  Analyzer EUDAMED
CA-810C Automatic Chemistry  Analyzer EUDAMED
Device Name
Automatic Chemistry  Analyzer EUDAMED
Model / Reference
URIT-8460、CA-430A、CA-430B、CA-810A、CA-640A、CA-640B、URIT-8280、CA-810B、CA-810C EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06935740725620 EUDAMED
06935740722773 EUDAMED
Basic UDI-DI
69357407ICA000001K3 EUDAMED
Direct Marketing DI
06935740725620 EUDAMED
06935740722773 EUDAMED
EMDN Code
W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMED
W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

CA-430B Automatic Chemistry Analyzer by URIT Medical Electronic Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
URIT Medical Electronic Co., Ltd.
EUDAMED SRN
CN-MF-000011840
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 9ad2a8c4-bcf9-4102-b53c-cecac3a663ff 61 fields · synced Oct 6, 2026
  • EUDAMED a86a46bb-6b76-49a0-842a-8be737804ffc 61 fields · synced May 18, 2026