Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Belt, Curved, Regular

UDI-DI 10810005340424Basic UDI-DI 081000534AXNXZ8

Class III · MDR · Axonics Inc.

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Identification

Model: —
EMDN: J020480
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 755443

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-07-13 · Expiry 2029-03-11

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

SRN US-MF-000008413

US · Irvine

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

Belt, Curved, Extended 10810005340431
Belt, Regular 10810005340264
Carrier 10810005340233
Charging System 10810005340011
Foramen Needle, Long 10810005340196
Foramen Needle, Short 10810005340189
Needle Test Stimulation Cable 10810005340240
Neurostimulator, Rechargeable 10810005340479
Neurostimulator, Rechargeable-Free 10810005340455
PNE Lead Implant Kit 10810005340134
Tined Lead Kit 10810005340141
Tined Lead Kit with Percutaneous Extension 10810005340158

Showing 12 of 15 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/belt-curved-regular-0424 · UDI page: /udi/10810005340424

All devices from Axonics Inc.

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