QT ECG Disposable Electrode Strip
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- QT ECG Disposable Electrode Strip EUDAMEDQT ECG FDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- QT ECG Disposable Electrode Strip EUDAMEDThe QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors. FDA UDI
- Model / Reference
- QTEOS125U EUDAMEDFDA UDI
- Description
- The QT ECG Disposable Electrode Strip is a self-adhesive, single use, one-piece integrated ECG electrode meant to use with QT ECG recorder. The design of the prepositioned Electrode Strip gives the user an easy way of applying the collection of electrodes in their correct locations, thereby reducing electrode placement errors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872981442 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987298014UNI001QF EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Electrocardiographic electrode, single-use
QT ECG Disposable Electrode Strip by QT Medical, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220795 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K180157 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471987298014UNI001QF | Class I | 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 8788cf6b-c983-407d-b918-0fa55e4bf5c5 61 fields · synced Jun 19, 2026
- FDA UDI 3db7bd71-8407-48e8-b8d9-061fe3ac6c4b 35 fields · synced May 30, 2026
- FDA 510(k) K220795 1 fields · synced May 18, 2026