Identity
- Trade Name
- Sunrise FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- Sunrise sensor 2 (single night) FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Sunrise sensor 2 (single night) FDA UDI
Identifiers
- Catalog Number
- A600 FDA UDI
- Primary DI / UDI-DI
- 05430001896091 FDA UDI
- 510(k) Number
- K222262 FDA UDI
- FDA Product Code
- QRS FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2376 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use sleep apnoea recording system
Sunrise by Sunrise — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Sunrise
Sources (1)
- FDA UDI 19ca11a9-c4f3-40f1-b233-f5584fcae746 37 fields · synced Jun 8, 2026