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SOMNOwatch plus ACTI
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SOWP100ZModel SOMNOwatch plus
Identity
- Trade Name
- Add on device SOMNOwatch plus ACTI EUDAMEDSOMNOwatch plus ACTI FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Model / Reference
- SOWP100Z EUDAMEDFDA UDISOMNOwatch plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413402748 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134SOMNOwatchplusAK EUDAMED
- 510(k) Number
- K081485 FDA UDI
- FDA Product Code
- MNR FDA UDI
- 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- 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
No
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 by Somnomedics GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Wearable multiple physiological parameter recorder, reusable.
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- SansaTM — Huxley Medical · Class II
Cleared under the same submission
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 | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Somnomedics GmbH
Sources (2)
- FDA UDI a00fec07-cecc-4147-ba90-8aaef388567b 33 fields · synced Jul 22, 2026
- EUDAMED 34fd9640-e363-435a-9e89-65a19b78437a 61 fields · synced Jul 22, 2026