Identity
- Trade Name
- ECG 2.0 App FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- ECG iPhone App (version 2.0) FDA UDI
- Model / Reference
- Feature Version 2.x FDA UDI
- Description
- ECG iPhone App (version 2.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190199649293 FDA UDI
- FDA Product Code
- QDA FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2345 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
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
Category: Cardiopulmonary physiological parameter analysis software
ECG 2.0 App by Apple Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary physiological parameter analysis software.
- LABSYSTEM™ PRO — Boston Scientific · Class I
- Viz HCM — Viz.ai · Class II
- ECG Plug-In — PREVENTICE TECHNOLOGIES, INC. · Class II
- Premier Heart MCG Analysis Software — PREMIER HEART, LLC · Class II
- PatientCare Platform — PREVENTICE TECHNOLOGIES, INC. · Class II
- Office Medic — Vectracor, Inc. · Class II
- RhythmAnalytics — Biofourmis Singapore Pte., Ltd. · Class II
- Premier Heart MCG Analysis API — PREMIER HEART, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Apple Inc.
Sources (2)
- FDA UDI 2dce21a0-2994-4b0f-b370-61c260f38f2d 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026