← Back to catalogue
SOMNOscreen plus Cardio RESP Screener Set
FDA UDIEUDAMEDFDA 510(k)510(k) K201054Ref SSP100Model SOMNOscreen plus
Identity
- Trade Name
- SOMNOscreen plus RC EUDAMEDSOMNOscreen plus Cardio RESP Screener Set FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- SOMNOscreen plus EUDAMEDSSP100 EUDAMEDSSP100U FDA UDI
Identifiers
- Catalog Number
- SSP100U FDA UDI
- Primary DI / UDI-DI
- 04250413400027 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: PolysomnographPolysomnography analyserPatient monitoring system module, multifunction
SOMNOscreen plus Cardio RESP Screener Set by Somnomedics GmbH — FDA_510K, MDR — listed in FDA GUDID, EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, multifunction.
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Avalon Patient Module — Philips Medizin Systeme Böblingen GmbH · Class II
- Vital Signs Patient Monitor — Dynarex Corp. · Class II
- Avalon TOCO+ Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- MPM Module (with MR ECG, NIBP, Temp) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- IBP_CO_SidestreamCO2 module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Benelink module package(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- EarlySense® Chair Sensor — Earlysense, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201054 | N/A | Active |
| EUDAMED | European Union | MDR | — | N/A | Unknown |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (3)
- FDA UDI 8029542d-02f0-4abe-8cd3-12c515ce438a 57 fields · synced Jul 12, 2026
- EUDAMED 20d7ad9f-6868-4321-b0ca-a1066305a270 61 fields · synced Jul 12, 2026
- FDA 510(k) K201054 1 fields · synced Jun 4, 2026