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MCM Composite Control
EUDAMEDClass B (EU MDR)
Ref 410203204Model level 1, Level 2
Identity
- Trade Name
- MCM Composite Control EUDAMED
- Device Name
- MCM Composite Control EUDAMED
- Model / Reference
- level 1, Level 2 EUDAMED410203204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235036872 EUDAMED
- Basic UDI-DI
- 697423503UCM0003JX EUDAMED
- Direct Marketing DI
- 06974235036872 EUDAMED
- EMDN Code
- W0101050207 URINE CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Romania 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 Composite 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 | 697423503UCM0003JX | 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 a2915bc0-bb18-4487-9cae-7c6d1bb93e34 61 fields · synced Sep 30, 2026