← Back to catalogue

MCC Physical Calibrator

EUDAMED

Class B (EU MDR)

Ref 410104011Model CA-500 and CM series urinalysis systemRef 410104007Ref 410104008

by Changchun Medicside Medical Technology Co., Ltd

Identity

Device Name
MCC Physical Calibrator EUDAMED
Model / Reference
CA-500 and CM series urinalysis system EUDAMED
410104011 EUDAMED
410104007 EUDAMED
410104008 EUDAMED

Identifiers

Primary DI / UDI-DI
06974235033413 EUDAMED
06974235033376 EUDAMED
06974235033383 EUDAMED
Basic UDI-DI
697423503UCA0005EX EUDAMED
Secondary DI
16974235033410 EUDAMED
16974235033373 EUDAMED
16974235033380 EUDAMED
Direct Marketing DI
06974235033413 EUDAMED
06974235033376 EUDAMED
06974235033383 EUDAMED
EMDN Code
W0101050302 CALIBRATORS SINGLE COMPONENT (CC) 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

MCC Physical Calibrator 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

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

Manufacturer

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

Sources (3)

  • EUDAMED 4a2826cb-089b-41e5-9717-95f8e61bfea6 61 fields · synced Jul 22, 2026
  • EUDAMED ce838e8c-4817-45c8-b3c4-b6cf45362140 61 fields · synced May 18, 2026
  • EUDAMED e2fbbd23-93ae-4fb8-8652-aa2773db96b6 61 fields · synced May 18, 2026