Identity
- Trade Name
- NeuVision 850 EUDAMED
- Device Name
- Digital Radiography System EUDAMED
- Model / Reference
- none EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970167440671 EUDAMED
- Basic UDI-DI
- 697016744000000000000033A EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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
NeuVision 850 by Neusoft Medical Systems Co., Ltd. — Class IIb — 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 | 697016744000000000000033A | Class IIb | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000011819
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c28593b7-060f-406e-a348-b29104789be3 61 fields · synced Oct 5, 2026