Identity
- Trade Name
- Noxturnal APP FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Model / Reference
- NOX-NOXTURNAL_APP FDA UDI
Identifiers
- Catalog Number
- 536210 FDA UDI
- Primary DI / UDI-DI
- 15694311110019 FDA UDI
- 510(k) Number
- K192469 FDA UDI
- FDA Product Code
- OLZ FDA UDIKZM FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI890.1375 FDA UDI
- Commercial Distribution
- Not 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
Noxturnal APP by Nox Medical ehf. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K192469 also covers:
- Nox A1 Carry Case — Nox Medical ehf.
- Nox A1 Recorder — Nox Medical ehf.
- Nox A1 Starter Sensor Kit, Adult — Nox Medical ehf.
- Nox A1 Starter Sensor Kit, Pediatric — Nox Medical ehf.
- Nox A1 System — Nox Medical ehf.
- Nox A1s Recorder — Nox Medical ehf.
- Nox A1® EEG 5 Lead Gold Electrode Cable — Nox Medical ehf.
- Nox A1® EEG Head Cable — Nox Medical ehf.
- Nox C1 Access Point — Nox Medical ehf.
- Nox C1 Kit — Nox Medical ehf.
- Nox C1 Kit — Nox Medical ehf.
- Nox C1s Kit — Nox Medical ehf.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 0e2dd240-5db7-4b2c-a4d8-71c9b7e98073 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026