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AXONICS, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Australia, Hong Kong, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 0Class III 3

plus 3 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

16active ARTG entries

Class I 3Class III 7IIa 4IIb 1Class Is (sterile) 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: AXONICS, INC.

FDA 510(k) clearances by year

41983 · K833298

11985 · K843712

FDA listed device types

Stimulator, Electrical, Implantable, For Incontinence 1Implanted Electrical Device Intended For Treatment Of Fecal Incontinence 1Agent, Bulking, Injectable For Gastro-Urology Use 1

Market	Identifier	Name	Class / date
US	K843712	AUDIT TM V	1985-04-05
US	K833298	AUDIT V AX 135	1983-12-01
US	K831870	ALLERGENETICS FLUORO-FAST READER	1983-08-12

AXONICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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