Identity
- Trade Name
- A1s System EUDAMEDNox A1s System FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Nox A1s System with WristOx2 EUDAMED
- Model / Reference
- NOX-A1S_EUF EUDAMED513012 EUDAMEDNOX-A1S_USF FDA UDI
Identifiers
- Catalog Number
- 513113 FDA UDI
- Primary DI / UDI-DI
- 15694311111573 EUDAMED15694311111580 FDA UDI
- Basic UDI-DI
- 1569431111NOX_A1KITQA EUDAMED
- FDA Product Code
- OLZ FDA UDIKZM FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI890.1375 FDA UDI
- Medical Purpose
- System/procedure pack consisting of CE-marked medical device(s) and accessories intended to be used together in accordance with their respective intended purposes. 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
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Polysomnograph
Nox A1s System by Nox Medical ehf. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polysomnograph.
- Snore Sensor — Respironics, Inc. · Class II
- SleepmateSnoring Microphone — Ambu A/S · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · Class II
- TriplePlay — Dymedix Diagnostics, Inc. · Class II
- Perfect Fit — Dymedix Diagnostics, Inc. · Class II
- micromed — Micromed, Inc. · Class II
- Cadwell — Cadwell Industries, Inc. · 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 | — | 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 6c8d738c-2515-4223-8feb-027682a4475e 34 fields · synced Jul 22, 2026
- EUDAMED c5b042b9-579a-4899-b9cc-f98638984cdc 61 fields · synced Jul 22, 2026