Identity
- Trade Name
- Provizio SEM Scanner Gateway FDA UDI
- Generic Name
- Localized oedema electrical impedance scanner FDA UDI
- Device Name
- Provizio SEM Scanner Gateway USB FDA UDI
- Model / Reference
- 02654 FDA UDI
- Description
- Provizio SEM Scanner Gateway USB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860740002654 FDA UDI
- 510(k) Number
- DEN170021 FDA UDI
- FDA Product Code
- QEF FDA UDI
- GMDN Term
- Localized oedema electrical impedance scanner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.2100 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Localized oedema electrical impedance scanner
Provizio SEM Scanner Gateway by Bruin Biometrics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Localized oedema electrical impedance scanner.
- Provizio SEM250 — Bruin Biometrics, LLC · Class I
- Provizio SEM Scanner S — Bruin Biometrics, LLC · Class I
- Provizio SEM Scanner — Bruin Biometrics, LLC · Class I
Cleared under the same submission
DEN170021 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bruin Biometrics, LLC
Sources (1)
- FDA UDI 0b7c41ba-f447-493d-a159-1ea320d85ca2 34 fields · synced Jun 9, 2026