Provizio SEM Scanner S
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Provizio SEM Scanner S EUDAMEDProvizio SEM Scanner S Sensor FDA UDI
- Generic Name
- Localized oedema electrical impedance scanner FDA UDI
- Device Name
- Provizio SEM Scanner S Single-Use Sensor EUDAMEDProvizio SEM Scanner S Sensor - Individual FDA UDI
- Model / Reference
- Provizio SEM Scanner S Single-Use Sensor EUDAMED02630 EUDAMEDFDA UDI
- Description
- Provizio SEM Scanner S Sensor - Individual FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860740002630 EUDAMEDFDA UDI
- Basic UDI-DI
- 08607400026026302B 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 I EUDAMEDFDA 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
Yes
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Provizio SEM Scanner S by Bruin Biometrics, LLC — Class I — 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 | 08607400026026302B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 db4514b4-4742-4635-987e-1dd24fc59c92 61 fields · synced Jul 12, 2026
- FDA UDI ff439cbf-1aea-4703-98b9-f328c20e1337 34 fields · synced May 30, 2026