Home›Denmark›TONICA ELEKTRONIK A/S

TONICA ELEKTRONIK A/S

Denmark · Farum

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 10 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

6listed device types

Class I 0Class II 6Class III 0

plus 19 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

5 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 3

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States19 registration records, 18 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: TONICA ELEKTRONIK A/S · Tonica Elektronik A/S

FDA 510(k) clearances by year

12006

12007

12010

12015

12016

52017

12018

12020

22023

32025

12026

FDA listed device types

Transcranial Magnetic Stimulator 1Stimulator, Muscle, Powered 1Stimulator, Electrical, Evoked Response 1Electromagnetic Stimulator, Pain Relief 1Neurological Stereotaxic Instrument 1Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260189	MagVenture Accelerated TMS (aTMS) Therapy System	2026-05-22
US	K251125	MagVenture TMS Therapy System	2025-08-11
US	K251119	MagVenture TMS Therapy System	2025-08-08
SA	ME0000008466SFDAA00019	Isolation Transformer	—
CA	7355	MAGPRO MAGNETIC STIMULATOR	Class III

TONICA ELEKTRONIK A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies