HomeItalyNICAL SPA

NICAL SPA

Italy · Milan (Mi) Lombardy
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Australia, Israel — 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 3 registration records and 3 510(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
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States3 registration records, 3 510(k), 0 PMA
Manufacturer names merged into this page: NICAL SPA

Company information

Country
Italy
City
Milan (Mi) Lombardy

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11996 · K951261
12006 · K053029
12015 · K143703

FDA listed device types

System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Extraoral Source, Digital 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

MarketIdentifierNameClass / date
USK143703NICAL SMART MICRO CR system for intraoral dental images2015-03-18
USK053029NDR+/DIVA-D2006-01-06
USK951261DFI-1000 AND DVS-475 IMAGING DEVICES1996-03-15

Similar companies

A UNO TEC SRL
Italy · markets 0
A.d.M. srl
Italy · markets 0
A.M.I. Italia S.r.l.
Italy · markets 2
Adamo S.r.l.
Italy · markets 0
ADRANOX SRL
Italy · markets 1
Adria S.r.l.
Italy · markets 3
Is this your company? Claim the page, add information or report a data error.Claim / report an error →