Identity
- Trade Name
- Somryst FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Model / Reference
- SOMRYST FDA UDI
Identifiers
- Catalog Number
- 651010 FDA UDI
- Primary DI / UDI-DI
- 15694311112112 FDA UDI
- 510(k) Number
- K191716 FDA UDI
- FDA Product Code
- QVO FDA UDI
- GMDN Term
- Mental health/function therapeutic software, screen-viewed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5801 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mental health/function therapeutic software, screen-viewed
Somryst by Nox Medical ehf. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mental health/function therapeutic software, screen-viewed.
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Cleared under the same submission
K191716 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nox Medical ehf.
Sources (1)
- FDA UDI 10a9bd02-c46f-4ecc-b52d-2f1f7c25f42b 34 fields · synced May 30, 2026