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Sleep Apnea Feature
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref v 1.0Model Sleep Apnea-Android510(k) DEN230041Ref v1.X
Identity
- Trade Name
- Sleep Apnea Feature EUDAMEDSamsung Sleep Apnea Feature (Android OS) FDA UDI
- Generic Name
- Patient general health self-management software FDA UDI
- Device Name
- Sleep Apnea Feature EUDAMEDThe Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders. FDA UDI
- Model / Reference
- Sleep Apnea-Android EUDAMEDv 1.0 EUDAMEDv1.X EUDAMED1.X FDA UDI
- Description
- The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806094936889 EUDAMEDFDA UDI
- Basic UDI-DI
- 8806094936896BY EUDAMED
- 510(k) Number
- DEN230041 FDA UDI
- FDA Product Code
- QZW FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient general health self-management software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2378 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Sleep Apnea Feature by Samsung Electronics Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN230041 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8806094936896BY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd.
- EUDAMED SRN
- KR-MF-000023537
- Authorised Representative
- Samsung Electronics GmbH DE-AR-000007005
Sources (4)
- EUDAMED 9f4f7b1a-3990-4b86-9ef8-8b9b83c31c38 85 fields · synced Jul 13, 2026
- FDA UDI 62fa6d67-cedf-4096-ba63-81a8aef38d9c 34 fields · synced May 30, 2026
- EUDAMED f6479099-7850-4fa1-92c6-f57cd180db4e 61 fields · synced Jul 13, 2026
- FDA 510(k) DEN230041 1 fields · synced May 18, 2026