Identity
- Trade Name
- QT ECG EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- QT ECG Recorder EUDAMEDThe QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. FDA UDI
- Model / Reference
- QTERD100 EUDAMEDFDA UDI
- Description
- The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872980414 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719872980414 EUDAMED
- 510(k) Number
- K180157 FDA UDI
- FDA Product Code
- DXH FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Height — 18.6 Millimeter FDA UDIWidth — 68.02 Millimeter FDA UDIDepth — 72 Millimeter FDA UDI
Qt Ecg by QT Medical, Inc. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233521 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04719872980414 | 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 (3)
- EUDAMED b93df368-510d-4f2e-9ab0-e221aa505e6b 61 fields · synced Jul 18, 2026
- FDA UDI d4e06a29-8084-473f-a3f9-4ece56c69e27 37 fields · synced May 30, 2026
- FDA 510(k) K233521 1 fields · synced May 18, 2026