QT ECG Disposable Electrode Strip (QHeart Sensor)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- QT ECG Disposable Electrode Strip (QHeart Sensor) EUDAMEDQHeart SENSOR 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
- QTEOS120U 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
- 04719872981633 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 (QHeart Sensor) by QT Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987298014UNI001QF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- QT Medical, Inc.
- EUDAMED SRN
- US-MF-000014384
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 20ef5eff-5ed7-4e05-9d5b-69e86d609ad0 61 fields · synced Jun 17, 2026
- FDA UDI f53be3e5-5155-4582-8a4f-2a30c52c9303 33 fields · synced May 30, 2026