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MCM Focus
EUDAMEDClass B (EU MDR)
Ref 410201003Model MA-500 and CM series urinalysis system
Identity
- Device Name
- MCM Focus EUDAMED
- Model / Reference
- MA-500 and CM series urinalysis system EUDAMED410201003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235033499 EUDAMED
- Basic UDI-DI
- 697423503UMA0001JR EUDAMED
- Secondary DI
- 16974235033496 EUDAMED
- Direct Marketing DI
- 06974235033499 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
Yes
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
MCM Focus 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 | 697423503UMA0001JR | 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 (1)
- EUDAMED 5abf6011-cdba-4b7e-b606-738d15f2fd15 61 fields · synced Jun 18, 2026