← Back to catalogue

CA-200 Automatic Chemistry Analyzer

EUDAMED

Class A (EU MDR)

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

by URIT Medical Electronic Co., Ltd.

Identity

Trade Name
CA-200 Automatic Chemistry  Analyzer EUDAMED
Device Name
Automatic Chemistry  Analyzer EUDAMED
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 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06935740719360 EUDAMED
Basic UDI-DI
69357407ICA000002K5 EUDAMED
Direct Marketing DI
06935740719360 EUDAMED
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) 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-200 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • EUDAMED 4fa722dd-7170-437c-8d87-c3a069a3e5d4 61 fields · synced Jul 13, 2026