Identity
- Trade Name
- NeviFile kit US FDA UDI
- Generic Name
- Neoplasm electrical impedance spectrometer electrode array FDA UDI
- Device Name
- NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network, immediately when an examination iscompleted and a report is created. FDA UDI
- Model / Reference
- 142-0013 FDA UDI
- Description
- NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network, immediately when an examination iscompleted and a report is created. FDA UDI
Identifiers
- Catalog Number
- 142-0013 FDA UDI
- Primary DI / UDI-DI
- 07350094440279 FDA UDI
- PMA Number
- P150046 FDA UDI
- FDA Product Code
- ONV FDA UDI
- GMDN Term
- Neoplasm electrical impedance spectrometer electrode array FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.1820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neoplasm electrical impedance spectrometer electrode array
NeviFile kit US by Scibase AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Scibase AB
Sources (1)
- FDA UDI 39c4780e-04bf-41a8-889b-6e960770c6d2 35 fields · synced Jun 8, 2026