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MC Urinalysis Strip

EUDAMED

Class B (EU MDR)

Ref 410101152Model CA-500 and CM series urinalysis system

by Changchun Medicside Medical Technology Co., Ltd

Identity

Device Name
MC Urinalysis Strip EUDAMED
Model / Reference
CA-500 and CM series urinalysis system EUDAMED
410101152 EUDAMED

Identifiers

Primary DI / UDI-DI
06974235032256 EUDAMED
Basic UDI-DI
697423503UCA0001EP EUDAMED
Secondary DI
16974235032253 EUDAMED
Direct Marketing DI
06974235032256 EUDAMED
EMDN Code
W0101060205 URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED) EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

MC Urinalysis Strip by Changchun Medicside Medical Technology Co., Ltd — Class B — 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

EUDAMED SRN
CN-MF-000022835
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED c603edbe-312b-4891-945a-e6a36d35bdd3 61 fields · synced Jun 18, 2026