Identity
- Trade Name
- Provizio SEM Scanner S EUDAMEDFDA UDI
- Generic Name
- Localized oedema electrical impedance scanner FDA UDI
- Device Name
- Provizio SEM Scanner S EUDAMEDProvizio SEM Scanner S - Disposable Sensor Head FDA UDI
- Model / Reference
- 02647 EUDAMEDFDA UDI
- Description
- Provizio SEM Scanner S - Disposable Sensor Head FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860740002647 EUDAMEDFDA UDI
- Basic UDI-DI
- 0860740002647TN EUDAMED
- Direct Marketing DI
- 00860740002647 EUDAMED
- 510(k) Number
- DEN170021 FDA UDI
- FDA Product Code
- QEF FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Localized oedema electrical impedance scanner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.2100 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Provizio SEM Scanner S by Bruin Biometrics, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0860740002647TN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bruin Biometrics, LLC
- EUDAMED SRN
- US-MF-000028418
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 666a5a37-6fd2-48ad-8ef7-f316d97a7e97 61 fields · synced Jul 9, 2026
- FDA UDI 633040d7-dcc8-4fe9-87cc-77f75cd0253f 34 fields · synced May 30, 2026