EU Manufacturer
🇺🇸 United States
Active
Axonics Inc.
SRN: US-MF-000008413
·
Sand Canyon Ave 15515, 92618 Irvine, United States
Basic UDI-DIs
24
Total Devices
24
On Market
24
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Sand Canyon Ave 15515, 92618 Irvine, United States
- [email protected]
- Phone
- +1 866 722 5738
- Website
- www.axonics.com
Regulatory Overview
Regulation
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Eu Aimdd
24
Classification
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Eu Aimdd Class
24
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| AIMDD Annex II Section 4 | 634655 | BSI Group The Netherlands B.V. | Dec 31, 2027 | |||
| AIMDD Annex II (excluding section 4) | 639686 | BSI Group The Netherlands B.V. | Dec 31, 2027 | |||
| AIMDD Annex II Section 4 | 634655 | BSI Group The Netherlands B.V. | Dec 31, 2027 | |||
| AIMDD Annex II (excluding section 4) | 639686 | BSI Group The Netherlands B.V. | Dec 31, 2027 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇳🇱 Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Axonics Accessory Dilator and Sheath | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory Tunneling Tool | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory Tunneling Tool and Directional Guide | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Basic Trial Cable | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Charging Belt - Extended Size | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Charging Belt - Regular Size | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Charging System Adhesive Carriers | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Foramen Needle - Long | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Foramen Needle - Short | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, J-Clip Stimulation Cable | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Lead Extension Cable | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Lead Stimulation Cable | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Stimulation Ground Cable | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Accessory, Torque Wrench | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Charging System | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Clinician Programmer (EPG/IPG) | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Lead Implant Kit | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Neurostimulator | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics PNE Lead | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics PNE Lead Implant Kit | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Remote Control | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Tined Lead | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Tined Lead (with Percutaneous Extension) | EU AIMDD | Eu Aimdd Class | On Market | 2 |
| Axonics Trial Stimulator | EU AIMDD | Eu Aimdd Class | On Market | 2 |