Eu Mdr
Eu Md Class 2a
On The Market
🇰🇷 South Korea
ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
Devices (same UDI-DI)
5
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08806092938823
- Basic UDI-DI Code
- 88060940602706J
- Reference
- 360049
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Samsung Electronics Co., Ltd.
Additional Description
This application is intended to create, record, store, transfer, and displays a single-channel electrocardiogram (ECG), similar to a Lead I ECG, using an ECG sensor mounted on a mobile platform (smartwatch). Classifiable traces are labeled by the application as either atrial fibrillation or sinus rhythm with the intention of aiding heart rhythm indentification.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050382 | ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES |
| Z12040182 | GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES |
Available In Countries
🇩🇪 Germany
Related Devices
The Basic UDI-DI associated with this device has 5 devices in total. Below are some other devices sharing the same Basic UDI-DI.
ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 2a
·Samsung Electronics Co., Ltd.·On the market·1 country
ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 2a
·Samsung Electronics Co., Ltd.·On the market·1 country
ELECTROCARDIOGRAPHS - SOFTWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 2a
·Samsung Electronics Co., Ltd.·On the market·1 country
GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 2a
·Samsung Electronics Co., Ltd.·On the market·1 country
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