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ECG app
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref ECG app 1.XModel 1.X510(k) DEN180044
by Apple Inc.
Identity
- Trade Name
- ECG App FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- ECG app EUDAMED
- Model / Reference
- 1.X EUDAMEDECG app 1.X EUDAMEDFeature Version 1.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190198909534 EUDAMEDFDA UDI00190198909541 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190198ECGAppMY EUDAMED
- Direct Marketing DI
- 00190198909534 EUDAMED00190198909541 EUDAMED
- 510(k) Number
- DEN180044 FDA UDI
- FDA Product Code
- QDA FDA UDI
- EMDN Code
- Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES EUDAMEDZ12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2345 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMEDIreland 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ECG app by Apple Inc. — 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
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 | DEN180044 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201525 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0190198ECGAppMY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- FDA Applicant
- Apple, Inc.
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (5)
- EUDAMED 8c2f610b-dfd4-4203-b527-a061040769d8 85 fields · synced Jul 21, 2026
- FDA UDI 6a7e8fd1-5a30-4841-80e5-a1ad0da713b4 33 fields · synced May 30, 2026
- FDA UDI 44bd3e74-b8f9-4d96-9e1f-0019810de75b 33 fields · synced May 30, 2026
- EUDAMED 4a3319aa-5004-45ac-9446-a4a21bdfe333 61 fields · synced Jul 21, 2026
- FDA 510(k) DEN180044 1 fields · synced May 18, 2026