COMPLETE VITAL SIGNS TELEMETRY SYSTEMS
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Basic Information
- Primary DI
- 00853858006324
- Basic UDI-DI Code
- B-00853858006324
- Reference
- E4
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Empatica S.r.L.
Additional Description
Wearable electronic device intended to be use for monitoring a set of physiological signals in daily file conditions such as: heart rate, skin conductance, body temperature, and activity information of the subject. The E4, is non intended to diagnose a disease or to be used by a trained medical professional, but will be useful for user that need to track those data in reliable and safe way, as if they are using a medical device, outside typical ambulatory conditions
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030601 | COMPLETE VITAL SIGNS TELEMETRY SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1876/MDD | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITร S.P.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).