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Sunrise

FDA UDI

Class II (US FDA UDI)

by Sunrise

Identity

Trade Name
Sunrise FDA UDI
Generic Name
Home-use sleep apnoea recording system FDA UDI
Device Name
Sunrise sensor 2 (multi-nights) FDA UDI
Model / Reference
2 FDA UDI
Description
Sunrise sensor 2 (multi-nights) FDA UDI

Identifiers

Catalog Number
A500 FDA UDI
Primary DI / UDI-DI
05430001896084 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

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

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

Similar devices

Also classified as Home-use sleep apnoea recording system.

Cleared under the same submission

K222262 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sunrise

Sources (1)

  • FDA UDI a7b95bff-3205-4a00-afbd-60a1882c18a5 37 fields · synced May 29, 2026