Identity
- Trade Name
- Nevisense FDA UDI
- Generic Name
- Neoplasm electrical impedance spectrometer FDA UDI
- Device Name
- Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score. Electrical impedance is a measure of a material’s overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue. FDA UDI
- Model / Reference
- 511-0001 FDA UDI
- Description
- Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score. Electrical impedance is a measure of a material’s overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue. FDA UDI
Identifiers
- Catalog Number
- 511-0001 FDA UDI
- Primary DI / UDI-DI
- 07350094440071 FDA UDI
- PMA Number
- P150046 FDA UDI
- FDA Product Code
- ONV FDA UDI
- GMDN Term
- Neoplasm electrical impedance spectrometer 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neoplasm electrical impedance spectrometer
Nevisense 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 d276066d-54d5-4a51-a1fa-6f046b524b14 35 fields · synced May 30, 2026