EU Manufacturer
🇺🇸 United States
Active
Noraxon USA, Inc.
SRN: US-MF-000003882
·
15770 N. Greenway Hayden Loop., 85260 Scottsdale, United States
Basic UDI-DIs
4
Total Devices
43
On Market
43
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- 15770 N. Greenway Hayden Loop., 85260 Scottsdale, United States
- [email protected]
- Phone
- 480 443 3413
- Website
- www.noraxon.com
Regulatory Overview
Regulation
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Eu Mdr
4
Classification
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Eu Md Class 1
4
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Clinical Receiver | EU MDR | Eu Md Class 1 | On Market | 0 |
| Clinical Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Core EMG Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Core Hub | EU MDR | Eu Md Class 1 | On Market | 0 |
| MyoSync | EU MDR | Eu Md Class 1 | On Market | 0 |
| NiNOX 120 Camera | EU MDR | Eu Md Class 1 | On Market | 0 |
| NiNOX 125 Camera | EU MDR | Eu Md Class 1 | On Market | 0 |
| NiNOX 300C Camera | EU MDR | Eu Md Class 1 | On Market | 0 |
| ResearchPRO Receiver | EU MDR | Eu Md Class 1 | On Market | 0 |
| ResearchPRO Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Single Solid Gel Electrode (Pouch of 30) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Solid Gel Dual Electrodes (QTY: 210) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Solid Gel Dual Electrodes (QTY: 30) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Torso Adapter Tape | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium 2D Goniometer SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Accelerometer SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Analog Input SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium BioMonitor SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Biofeedback App | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Sensor Tape | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Smart Lead (11”) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Smart Lead (3”) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium EMG Smart Lead (7”) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium FlexiForce SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Footswitch SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Handgrip Dynamometer SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Insole Sensor (L) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Insole Sensor (M) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Insole Sensor (S) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Insole Sensor (XL) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Insole SmartLead | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Linear Force SmartLead (100lbf) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Linear Force SmartLead (500lbf) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Motion Sensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Motion Strap Variations | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Receiver | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Sensor Charger | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ultium Sensor Tape | EU MDR | Eu Md Class 1 | On Market | 0 |
| myoMOTION Charging Station | EU MDR | Eu Md Class 1 | On Market | 0 |
| myoMOTION Sensor Strap Variations | EU MDR | Eu Md Class 1 | On Market | 0 |
| myoRESEARCH - myoMOTION Software Module | EU MDR | Eu Md Class 1 | On Market | 0 |
| myoRESEARCH - myoMUSCLE Software Module | EU MDR | Eu Md Class 1 | On Market | 0 |