Home›Austria›G.TEC MEDICAL ENGINEERING GMBH

G.TEC MEDICAL ENGINEERING GMBH

Austria · Schiedlberg

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 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

7listed device types

Class I 0Class II 7Class III 0

plus 10 registration records and 6 510(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

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States10 registration records, 6 510(k), 0 PMA, 45 excluded

Brazil0 confirmed, 20 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: G.TEC MEDICAL ENGINEERING GMBH

FDA 510(k) clearances by year

12006 · K060803

12012 · K123255

12017 · K171669

12018 · K173684

22020 · K200088

FDA listed device types

Stimulator, Neuromuscular, External Functional 1Stimulator, Muscle, Powered 1Amplifier, Physiological Signal 1Electrode, Cutaneous 1Electrode, Cortical 1Non-Normalizing Quantitative Electroencephalograph Software 1Normalizing Quantitative Electroencephalograph Software 1

Market	Identifier	Name	Class / date
US	K200088	g.Estim FES	2020-10-29
US	K191432	cortiQ PRO	2020-01-24
US	K173684	g.Estim PRO	2018-05-04

G.TEC MEDICAL ENGINEERING GMBH

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