Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Active-implantable devices
/
Implantable neurostimulators
/
Sacral spine implantable neurostimulators
Sacral spine implantable neurostimulators
J0204
24 devices
Subcategories
5
J020401
Bladder incontinence neurostimulators
1
device
J020402
Intestinal incontinence neurostimulators
0
devices
J020403
Sacral spine neurostimulation leads
3
devices
J020480
Sacral spine implantable neurostimulators - accessories
20
devices
J020499
Sacral spine implantable neurostimulators - other
0
devices
Devices
Pinktens
Bluetens limited
·
,
CN
Class IIa
CE/MDR
Axonics Neurostimulator
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
GUDID
on market
Axonics Tined Lead
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics PNE Lead
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDR
CE/MDD
+1
authorizations
Axonics Tined Lead (with Percutaneous Extension)
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics Lead Implant Kit
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDR
MDR 755443
Active
Valid to Mar 2029
CE/MDD
+1
authorizations
Axonics Accessory Tunneling Tool and Directional Guide
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
Axonics Clinician Programmer (EPG/IPG)
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics Accessory, J-Clip Stimulation Cable
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDR
CE/AIMDD
+1
authorizations
Axonics Accessory, Charging Belt - Regular Size
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics Accessory, Lead Extension Cable
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
GUDID
on market
Axonics Accessory, Torque Wrench
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDR
MDR 755443
Active
Valid to Mar 2029
CE/AIMDD
+1
authorizations
Axonics Accessory, Stimulation Ground Cable
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDD
GUDID
on market
Axonics Accessory, Foramen Needle - Long
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDR
CE/AIMDD
+1
authorizations
Axonics Charging System
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics Accessory Tunneling Tool
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDD
CE/AIMDD
Axonics Accessory, Foramen Needle - Short
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
GUDID
on market
Axonics Accessory, Basic Trial Cable
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Axonics Accessory Dilator and Sheath
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/MDD
GUDID
on market
Axonics Remote Control
Axonics Inc.
·
,
US
Active implantable (AIMDD)
CE/AIMDD
CE/MDR
MDR 755443
Active
Valid to Mar 2029
+1
authorizations
Previous
Next