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ECG App
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref v1.3Model ECG App 510(k) K240909
Identity
- Trade Name
- ECG App EUDAMEDSamsung ECG Monitor App 1.3 (with High HR_Android OS) FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- ECG Android EUDAMEDThe ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. FDA UDI
- Model / Reference
- ECG App EUDAMEDv1.3 EUDAMED1.3 FDA UDI
- Description
- The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806094948240 EUDAMEDFDA UDI
- Basic UDI-DI
- 88060940602706J EUDAMED
- FDA Product Code
- QDB FDA UDIQDA FDA UDI
- EMDN Code
- Z12040182,Z12050382 EUDAMED
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2790 FDA UDI870.2345 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
Yes
EUDAMED
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
ECG App 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 | K240909 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88060940602706J | 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 (3)
- EUDAMED 10a3ac73-b999-4f9a-a693-477fa0081fee 85 fields · synced Jun 18, 2026
- FDA UDI 4fbef44c-b498-43e7-a476-2aac689869f4 33 fields · synced May 30, 2026
- FDA 510(k) K240909 1 fields · synced May 18, 2026