Eu Mdr
Eu Md Class 1
On The Market
🇺🇸 United States
Ultium BioMonitor SmartLead
Devices (same UDI-DI)
26
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00816271020520
- Basic UDI-DI Code
- 081627102EMGACCYN
- Reference
- 852
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Noraxon USA, Inc.
Additional Description
Accessory to the Ultium EMG sensor (#810) which is designed to detect the heart rate and respiration rate of the subject utilizing electrodes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12100480 | ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES |
Related Devices
The Basic UDI-DI associated with this device has 26 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Ultium Insole Sensor (XL)
Device
EU MDR
·
Eu Md Class 1
·Noraxon USA, Inc.·On the market
Ultium Insole Sensor (L)
Device
EU MDR
·
Eu Md Class 1
·Noraxon USA, Inc.·On the market
Ultium Insole Sensor (S)
Device
EU MDR
·
Eu Md Class 1
·Noraxon USA, Inc.·On the market
Ultium Insole Sensor (M)
Device
EU MDR
·
Eu Md Class 1
·Noraxon USA, Inc.·On the market
Ultium EMG Sensor Tape
Device
EU MDR
·
Eu Md Class 1
·Noraxon USA, Inc.·On the market
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