Identity
- Trade Name
- NeuViz 128 EUDAMEDNeuViz 128 Multi-Slice CT Scanner System FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- MULTI-SLICE CT SCANNER SYSTEM EUDAMED
- Model / Reference
- none EUDAMEDNeuViz 128 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970167441616 EUDAMEDFDA UDI
- Basic UDI-DI
- 6970167440000000000000034 EUDAMED
- 510(k) Number
- K230220 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeuViz 128 by Neusoft Medical Systems Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970167440000000000000034 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 2e0cb9c8-1b04-494d-9651-34a8e85fcbf4 61 fields · synced Jun 15, 2026
- FDA UDI 580a8b5f-3ff0-4caa-b0cb-e850f12d088c 33 fields · synced May 30, 2026