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Axonics 4101

by Axonics Modulation Technologies, Inc.

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

Ref 4101

Axonics 4101 is a Class III device made by Axonics Modulation Technologies, Inc., registered in EUDAMED on 21 Mar 2024 (Basic UDI-DI 081000534AXNXZ8) with CE/MDR certificate MDR 755443 valid until 11 Mar 2029 and listed in FDA GUDID since 11 Mar 2022 (UDI-DI 10810005340455), active as of 25 Oct 2026.

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

CE MDR

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 755443 Date13 Jul 2026IssuedStatusActive expires 11 Mar 2029
United StatesGUDID listing GUDID Number10810005340455 UDI-DI Date11 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000534AXNXZ8 registered 21 Mar 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10810005340455 listed 11 Mar 2022 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 10810005340455
  2. Registered EUDAMED 081000534AXNXZ8
  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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Neurostimulator, Rechargeable-Free EUDAMED
Axonics GUDID
Generic name
Sacral plexus implantable incontinence-control electrical stimulation system
Device name
Axonics Sacral Neuromodulation System
Model / Ref / Catalog
4101
Primary DI / UDI-DI
10810005340455
Basic UDI-DI
081000534AXNXZ8
FDA product code
EZW, QON
EMDN code
J020401, J020402
GMDN term
Sacral plexus implantable incontinence-control electrical stimulation system
Device class
Class III
Regulation number
876.5270
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10810005340455: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Similar devices in this category

Other devices filed under IMPLANTABLE NEUROSTIMULATORS.

Other devices from Axonics Modulation Technologies, Inc.

  • Axonics 1401

    Class III

  • Axonics 5101

    Class III

  • Axonics FFG-01 Open recall

    Class III

  • Axonics 9108-R

    Class III

See all devices from Axonics Modulation Technologies, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)