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Axonics Remote Control

by Axonics Inc.

Part of a family of 27 devices: see the family page

Ref 2301

Axonics Remote Control (2301) is a medical device (EU AIMDD; EU AIMDD Class III; FDA Class III; EMDN category sacral spine implantable neurostimulators - accessories) made by Axonics Inc., registered in EUDAMED on 10 May 2024 (Basic UDI-DI B-10810005340103) with CE/MDR certificate MDR 755443 valid until 11 Mar 2029 and listed in FDA GUDID since 23 Sep 2019 (UDI-DI 10810005340103), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR CE AIMDD

Valid until

11 Mar 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 755443 Date13 Jul 2026IssuedStatusActive expires 11 Mar 2029
European UnionCE/AIMDD EUDAMED NumberB-10810005340103 Basic UDI-DI 10810005340103UDI-DIDate10 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10810005340103 UDI-DI Date23 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10810005340103 registered 10 May 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10810005340103 listed 23 Sep 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 755443 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    13 Jul 2026
    Expires
    11 Mar 2029
    Reason
    Other

Timeline

4 dated events

  1. Listed FDA GUDID 10810005340103
  2. Registered EUDAMED B-10810005340103
  3. Certificate issued EUDAMED MDR 755443
  4. Certificate expires EUDAMED MDR 755443

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/AIMDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Axonics Remote Control EUDAMED
Patient Remote Control EUDAMED
Axonics GUDID
Generic name
Implantable incontinence-control electrical stimulation system programmer, battery-powered
Device name
Axonics Sacral Neuromodulation System
Model / Ref / Catalog
2301
Primary DI / UDI-DI
10810005340103
Basic UDI-DI
B-10810005340103, 081000534AXNXZ8
FDA product code
QON, EZW
EMDN code
J020480 Sacral spine implantable neurostimulators - accessories
GMDN term
Implantable incontinence-control electrical stimulation system programmer, battery-powered
Device class
Class AIMDD EUDAMED
Class III EUDAMEDGUDID
Regulation number
876.5270
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class AIMDD
Class III
GUDID
Class III
ImplantableEUDAMED
No
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
US-MF-000008413
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under IMPLANTABLE NEUROSTIMULATORS.

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Properties

  • Implantable NoEUDAMEDGUDIDYesEUDAMED
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)