Identity
- Trade Name
- SOMNOscreen plus PSG+ AASM EUDAMEDSOMNOscreen plus PSG+ AASM Set FDA UDI
- Generic Name
- Polygraph FDA UDI
- Model / Reference
- SOMNOscreen plus EUDAMEDSSP201A EUDAMEDSSP201AU FDA UDI
Identifiers
- Catalog Number
- SSP201AU FDA UDI
- Primary DI / UDI-DI
- 04250413401932 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134SOMNOscreenplusEQ EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polygraph 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: PolysomnographPolysomnography analyserPolygraph
SOMNOscreen plus PSG+ AASM 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
- SOMNOscreen plus EEG32 Tele Set — Somnomedics GmbH
- 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
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 2376de97-192e-475b-b428-21f213e88e0a 33 fields · synced Jul 11, 2026
- EUDAMED e505126a-bb16-4d4a-b5e3-9ee569a9d3fa 61 fields · synced Jul 11, 2026