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Tomtec Imaging Systems, Inc.

Germany · Unterschleissheim

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Israel — 6 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 3Class III 0

plus 5 registration records and 23 510(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

17active device licences

Class II 17

21 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States5 registration records, 23 510(k), 0 PMA, 2 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: TOMTEC Imaging Systems GMBH · TOMTEC IMAGING SYSTEMS GMBH

FDA 510(k) clearances by year

11995

11996

21999

12000

12001

22002

12004

12007

22008

12009

42011

22012

12013

12015

12020

12022

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213544	TOMTEC-ARENA	2022-01-06
US	K201632	TOMTEC-ARENA	2020-08-14
US	K150122	TOMTEC-ARENA TTA2	2015-02-13
CA	71369	3D SONO-SCAN PRO SOFTWARE	Class II
CA	71370	4D LV-FUNCTION SOFTWARE	Class II
CA	71662	4D ECHO-VIEW SOFTWARE	Class II

Tomtec Imaging Systems, 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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