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all in one monitor
EUDAMEDClass I (EU MDR)
Ref 10205008-1Model AIOS322,AIOS323,AIOS324,AIOS430,AIOS431,AIOS432,AIOS433,AIOS434,AIOS435,AIOS436,AIOS550,AIOS551,AIOS552,AIOS4S,AIOS5S,AIOS6S,AIOS7S
Identity
- Trade Name
- all in one monitor EUDAMED
- Device Name
- all in one monitor EUDAMED
- Model / Reference
- AIOS322,AIOS323,AIOS324,AIOS430,AIOS431,AIOS432,AIOS433,AIOS434,AIOS435,AIOS436,AIOS550,AIOS551,AIOS552,AIOS4S,AIOS5S,AIOS6S,AIOS7S EUDAMED10205008-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977371932718 EUDAMED
- Basic UDI-DI
- 697737193AIO2Q2 EUDAMED
- Direct Marketing DI
- 06977371932718 EUDAMED
- EMDN Code
- Z11900880 BIOIMAGING VISUALIZATION AND/OR DIAGNOSTIC REPORT VIEWING MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
all in one monitor by Nanjing Kaiying Intelligent Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697737193AIO2Q2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000041141
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e4915e91-512f-41aa-b724-ffb3a4ac2078 61 fields · synced Oct 6, 2026