Identity
- Trade Name
- QT ECG APP EUDAMED
- Device Name
- QT ECG App EUDAMED
- Model / Reference
- iOS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872981060 EUDAMED
- Basic UDI-DI
- 471987298QTECGAPPQE EUDAMED
- EMDN Code
- Z12050382 ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Qt Ecg App by QT Medical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987298QTECGAPPQE | Class IIa | Active |
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Manufacturer
- Manufacturer
- QT Medical, Inc.
- EUDAMED SRN
- US-MF-000014384
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a8c27b62-11b7-401b-ab72-79a27599706a 61 fields · synced Jun 19, 2026