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MCC Physical Control
EUDAMEDClass B (EU MDR)
Ref 410105011Model CA-500 and CM series urinalysis systemRef 410105010Ref 410105008
Identity
- Device Name
- MCC Physical Control EUDAMED
- Model / Reference
- CA-500 and CM series urinalysis system EUDAMED410105011 EUDAMED410105010 EUDAMED410105008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235033475 EUDAMED06974235033468 EUDAMED06974235033444 EUDAMED
- Basic UDI-DI
- 697423503UCA0004EV EUDAMED
- Secondary DI
- 16974235033472 EUDAMED16974235033465 EUDAMED16974235033441 EUDAMED
- Direct Marketing DI
- 06974235033475 EUDAMED06974235033468 EUDAMED06974235033444 EUDAMED
- EMDN Code
- W0101050207 URINE CONTROLS 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 Control 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697423503UCA0004EV | Class B | Active |
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Manufacturer
- Manufacturer
- Changchun Medicside Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000022835
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 7645d582-fc02-4d32-8343-3de1121ce66c 61 fields · synced Jul 23, 2026
- EUDAMED 08c02201-3b23-44cd-bf5b-65c2c1c18ca9 61 fields · synced May 17, 2026
- EUDAMED 0b04a5f0-35f2-444f-91c5-169ac295d82b 61 fields · synced May 18, 2026