Identity
- Trade Name
- Lunoa FDA UDI
- Generic Name
- Sleep apnoea bed pillow FDA UDI
- Device Name
- Lunoa Sleep Position Trainer, US FDA UDI
- Model / Reference
- L1US01US FDA UDI
- Description
- Lunoa Sleep Position Trainer, US FDA UDI
Identifiers
- Catalog Number
- L1US01US FDA UDI
- Primary DI / UDI-DI
- 08719689344504 FDA UDI
- 510(k) Number
- K180608 FDA UDI
- FDA Product Code
- MYB FDA UDI
- GMDN Term
- Sleep apnoea bed pillow FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sleep apnoea bed pillow
Lunoa by NightBalance Holding B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lunoa — NightBalance Holding B.V. · Class II
Cleared under the same submission
K180608 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 |
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Manufacturer
- Manufacturer
- NightBalance Holding B.V.
Sources (1)
- FDA UDI 6d401458-8f52-4cea-8a45-255c8c4c073a 37 fields · synced May 30, 2026