Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00860004541776
- Basic UDI-DI Code
- 08600045417SA-020DX
- Reference
- SA-020
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Sibel Health Inc.
Additional Description
ADAM is a wireless monitoring system that collects 3-axis accelerometry data. The sensor is applied to the skin with a single-use, biocompatible adhesive. The ADAM sensor can send the actigraphy data via Bluetooth to compatible software applications that follow the device’s communication protocol. Data is also stored on the device itself.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).
ORTHODONTIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·LEONE S.P.A.·On the market·32 countries
Catalyst 5
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 4
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 5VX
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Spark
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Clik
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market