← Back to catalogue
SOMNOwatch plus ACTI + PLM (Activity)
FDA UDIEUDAMEDRef SOWP311Model SOMNOwatch plus
Identity
- Trade Name
- SOMNOwatch plus ACTI + PLM Analysis (Activity) EUDAMEDSOMNOwatch plus ACTI + PLM (Activity) FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Model / Reference
- SOWP311 EUDAMEDFDA UDISOMNOwatch plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413406098 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134SOMNOwatchplusAK EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The SOMNOwatch™ plus is a portable, miniaturized multi-channel measuring system for recording physiological signals on an outpatient basis. The SOMNOwatch™ plus helps the doctor to diagnose 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
SOMNOwatch plus ACTI + PLM (Activity) by Somnomedics GmbH — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple physiological parameter recorder, reusable.
- BioButton At-Home Kit — BIOINTELLISENSE, INC. · Class II
- circul pro, x-large — Bodimetrics, LLC · Class II
- SansaTM — Huxley Medical · Class II
- ANNE™ One — Sibel Health Inc. · Class II
- AcuPebble — Acurable Limited · Class II
- Wearable Patch — ATLAS LIFT TECH, INC. · Class I
- BioButton (Reprocessed, NF Version) — BIOINTELLISENSE, INC. · Class II
- SansaTM — Huxley Medical · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (2)
- FDA UDI ce6c8dd5-b282-4d06-992c-110e533f8836 32 fields · synced Jul 8, 2026
- EUDAMED 73932941-3daf-4c6d-84ea-0da8072ca6bf 61 fields · synced Jun 18, 2026