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ECG app
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ECG app 2.XModel 2.X
by Apple Inc.
Identity
- Trade Name
- ECG 2.0 App FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- ECG app EUDAMEDECG Watch App (version 2.0) FDA UDI
- Model / Reference
- 2.X EUDAMEDECG app 2.X EUDAMEDFeature Version 2.x FDA UDI
- Description
- ECG Watch App (version 2.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190199649286 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190199ECGApp2QP EUDAMED
- Direct Marketing DI
- 00190199649286 EUDAMED
- FDA Product Code
- QDA FDA UDI
- EMDN Code
- Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE 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 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0190199ECGApp2QP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Apple Inc.
- EUDAMED SRN
- US-MF-000013709
- Authorised Representative
- Apple Distribution International Limited IE-AR-000012406
Sources (2)
- EUDAMED 42a83065-4f0e-428c-bba2-6af60a5ea73e 61 fields · synced Jul 26, 2026
- FDA UDI 77658985-fd35-451c-a271-8c69ac73332e 33 fields · synced May 30, 2026