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Sign in to claim this brandQT Medical, Inc.
United States·US-MF-000014384
Last updated May 30, 2026
What QT Medical, Inc. makes
QT Medical, Inc. manufactures single-use electrocardiographic electrodes, reusable electrocardiographic lead sets, and multichannel professional and home-use electrocardiographs. Their devices are designed for cardiac monitoring and diagnostic purposes, including single-lead and multi-lead ECG recording systems.
The company’s products are regulated under FDA 510(k) clearance and listed in the FDA’s UDI system, with some devices classified as Class I and others as Class II or Class IIa. Their devices are also registered in the EU’s eudamed database, reflecting their global distribution and compliance with relevant medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does QT Medical, Inc. manufacture?
QT Medical, Inc. specializes in electrocardiographic (ECG) devices, including single-use electrodes, reusable lead sets, and both professional multichannel and home-use electrocardiographs. These products are designed for cardiac monitoring and diagnostic purposes, such as recording single-lead or multi-lead ECG signals.
Where is QT Medical, Inc. based, and where are its devices listed for regulatory compliance?
QT Medical, Inc. is based in the United States. Its devices are registered in multiple global regulatory databases, including the EU’s eudamed system and the FDA’s 510(k) clearance and UDI (Unique Device Identification) databases. This reflects compliance with both U.S. and European medical device regulations.
How are QT Medical, Inc.’s devices classified under regulatory frameworks?
QT Medical’s devices fall under different regulatory classifications depending on their design and risk level. Most of its products are classified as Class I (low risk) or Class II/IIa (moderate risk) under FDA guidelines. These classifications determine the regulatory pathway for authorization, such as 510(k) clearance for Class II devices.
Are QT Medical, Inc.’s devices available in international markets, and how is compliance ensured?
Yes, QT Medical’s devices are distributed globally, as evidenced by their registration in the EU’s eudamed database. Compliance is ensured through adherence to regulatory requirements in each market, including FDA clearance in the U.S. and conformity assessments for EU distribution, though the company itself is not certified—individual devices must meet authorization criteria.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1370, Valley Vista Drive, Suite 266, Diamond Bar, United States
- Website
- www.qtmedical.com/
- —
- —
- [email protected]
- Phone
- +1 909 323 0007
- PRRC Contact
- Jui-Hung Hung
- EUDAMED SRN
- US-MF-000014384
- FDA FEI Number
- —
- DUNS Number
- 078875059
Catalogue (57)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pca 500+ | QTERD100 | EUDAMED | Class IIa | Active |
| PCA-C101BS Patient Cable | PCA-C101BS | EUDAMED | Class I | Active |
| Pca 300 | QTERD100 | EUDAMEDFDA UDI | Class IIa | Active |
| PCA-A300 ECG Cable Converter | PCA-A300 | EUDAMEDFDA UDI | Class I | Active |
| PCA-C100BS Patient Cable | PCA-C100BS | EUDAMEDFDA UDI | Class I | Active |
| QT ECG Disposable Electrode Strip | QTEOS125U | EUDAMEDFDA UDI | Class I | Active |
| QT ECG Disposable Electrode Strip | QTEOS126U | EUDAMEDFDA UDI | Class I | Active |
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