Home›Italy›DE GOTZEN S.R.L.

DE GOTZEN S.R.L.

Italy · Fagnano Olona

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, Russia — 4 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

4listed device types

Class I 0Class II 4Class III 0

plus 8 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

3active device licences

Class II 3

15 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 States8 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: DE GOTZEN S.R.L.

FDA 510(k) clearances by year

12014 · K132378

12016 · K160166

32020 · K201382

FDA listed device types

X-Ray, Tomography, Computed, Dental 1System, Image Processing, Radiological 1System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201382	X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)	2020-11-18
US	K191719	X-MIND Trium	2020-02-20
US	K192165	Acteon Imaging Suite	2020-02-11
CA	79940	X-MIND EVO	Class II
CA	90644	X-MIND DX	Class II
CA	91639	X-MIND EVO 3D	Class II

DE GOTZEN S.R.L.

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