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VILLA SISTEMI MEDICALI S.P.A.

Italy · Buccinasco

✓ Record-verifiedregistrations found in 5 markets

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

5listed device types

Class I 0Class II 5Class III 0

plus 2 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

7active device licences

Class II 5Class III 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

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 States2 registration records, 13 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: VILLA SISTEMI MEDICALI S.P.A. · Villa Sistemi Medicali S.p.A.

FDA 510(k) clearances by year

21999

22000

22003

12005

12008

12009

12011

12013

12017

12018

FDA listed device types

Device, Beam Limiting, X-Ray, Diagnostic 1Table, Radiologic 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Device, Spot-Film 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180601	Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)	2018-11-02
US	K162190	Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)	2017-07-06
US	K130109	ENDOGRAPH DC	2013-08-01
SA	ME0000003299SFDAA00002	MOVIPLAN 800	—
CA	65401	DC RADIOGRAPHIC DIAGNOSTIC DENTAL X-RAY	Class II
CA	65402	AC/ACP RADIOGRAPHIC DIAGNOSTIC DENTAL X-RAY	Class II
CA	65403	STRATO 2000	Class II

VILLA SISTEMI MEDICALI S.P.A.

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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