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SOMNOscreen plus EEG32 Tele Set
FDA UDIEUDAMEDRef SBT719PModel SOMNOscreen plus
Identity
- Trade Name
- SOMNOscreen plus EEG 32 Tele (BT) EUDAMEDSOMNOscreen plus EEG32 Tele Set FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- SOMNOscreen plus EUDAMEDSBT719P EUDAMEDSBT719PU FDA UDI
Identifiers
- Catalog Number
- SBT719PU FDA UDI
- Primary DI / UDI-DI
- 04250413401963 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, multifunctionPolygraph
SOMNOscreen plus EEG32 Tele Set by Somnomedics GmbH — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polygraph.
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
- SOMNOtouch RESP Add-on device — Somnomedics GmbH
- SOMNOtouch RESP — Somnomedics GmbH · Class II
- AASM Headbox — Somnomedics GmbH
- Simplified Sleep Stage Evaluation for SOMNOtouch RESP — Somnomedics GmbH
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
- 1-channel EEG option for SOMNOtouch RESP — Somnomedics GmbH · Class II
- SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
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 f043016e-a7b1-4c7a-81a6-bd2b8b81c054 33 fields · synced Jul 9, 2026
- EUDAMED 35e42b45-0af9-4b36-91a3-cd915195ccfd 61 fields · synced Jul 9, 2026