Identity
- Trade Name
- NeuViz ACE 128 EUDAMEDNeuViz ACE EUDAMED
- Device Name
- MULTI-SLICE CT SCANNER SYSTEM EUDAMED
- Model / Reference
- none EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970167440411 EUDAMED06970167440329 EUDAMED
- Basic UDI-DI
- 6970167440000000000000034 EUDAMED
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMEDZ11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMEDIreland 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
NeuViz ACE 128 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 | 6970167440000000000000034 | 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 (2)
- EUDAMED 78bcbaca-d6c8-4fbe-b16f-6eda732063f3 61 fields · synced Jul 31, 2026
- EUDAMED 7000bd12-c46e-476d-b0d6-8923c4ab902b 61 fields · synced May 18, 2026