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SOMNOscreen plus PSG+ Tele Camera Compact AASM Set
FDA UDIEUDAMEDRef SBTV202AModel SOMNOscreen plus
Identity
- Trade Name
- SOMNOscreen plus PSG+ Tele (BT) and PTZ Camera AASM EUDAMEDSOMNOscreen plus PSG+ Tele Camera Compact AASM Set FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- SOMNOscreen plus EUDAMEDSBTV202A EUDAMEDSBTV202AU FDA UDI
Identifiers
- Catalog Number
- SBTV202AU FDA UDI
- Primary DI / UDI-DI
- 04250413401956 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 PSG+ Tele Camera Compact AASM Set 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 d4806e41-2d9e-4eef-be4c-d00764d00806 33 fields · synced Jul 8, 2026
- EUDAMED 5e558c20-1073-46ad-a8f4-888bbaab5768 61 fields · synced Jun 18, 2026