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SOMNOscreen plus EEG32 Tele Camera
FDA UDIEUDAMEDRef SBTV719PModel SOMNOscreen plus
Identity
- Trade Name
- SOMNOscreen plus EEG 32 Tele (BT) and PTZ Camera EUDAMEDSOMNOscreen plus EEG32 Tele Camera FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- SOMNOscreen plus EUDAMEDSBTV719P EUDAMEDSBTV719PU FDA UDI
Identifiers
- Catalog Number
- SBTV719PU FDA UDI
- Primary DI / UDI-DI
- 04250413409051 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134SOMNOscreenplusEQ EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNOscreen™ plus is a portable device for continuous recording of physiological signals. It can serve the physician as a polysomnography (PSG) system to assist in the diagnosis of sleep disorders. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
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: PolysomnographPatient monitoring system module, multifunction
SOMNOscreen plus EEG32 Tele Camera by Somnomedics GmbH — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (2)
- FDA UDI 4970010f-de14-4a26-b67b-26f4845388f4 33 fields · synced Jun 19, 2026
- EUDAMED 51186977-0e92-49b7-9ca4-ab6cc62d68e4 61 fields · synced Jun 14, 2026