Eu Mdd
Eu Md Class 2a
On The Market
🇮🇱 Israel
smartheart
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 07290008960380
- Basic UDI-DI Code
- B-07290008960380
- Reference
- E-XXX-X
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- SHL Telemedicine International Ltd.
Additional Description
The Smartheart is a personal, body-worn 12 lead ECG device with Bluetooth communication. The Smartheart acquires ECG data via permanently attached electrodes and transmits the data in real-time to a suitable Bluetooth communication device or cellphone for forwarding 12-lead ECG to a remote location equipped with the Cardio Monitor Center Vision software where it can be reviewed by a certified medical professional that is capable of interpreting the results.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050803 | ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 87756CE02 | DEKRA Certification B.V. | Expired |
Available In Countries
🇳🇴 Norway
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