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EUDAMED last updated this device on May 11, 2024
B-10810005340066Axonics Neurostimulator is an AIMDD-legacy active implantable device registered in EUDAMED. It is classified as AIMDD. Manufactured by Axonics Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
108100053400661101(01)10810005340066
European Medical Device Nomenclature — the EU product classification assigned to this device.
J020402INTESTINAL INCONTINENCE NEUROSTIMULATORSJ020401BLADDER INCONTINENCE NEUROSTIMULATORS9 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
US-MF-000008413634655639686Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-10810005340011On the marketAxonics Clinician Programmer (EPG/IPG)B-10810005340035On the marketAxonics Lead Implant KitB-10810005340080On the marketAxonics PNE LeadB-10810005340127On the marketAxonics PNE Lead Implant KitB-10810005340134On the marketAxonics Remote ControlB-10810005340103On the marketCertificate health across this manufacturer's portfolio.
MDR 755443SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.