HomeItalyTECNIMED S.r.l.

TECNIMED S.r.l.

Italy · Vedano Olona (VA) · www.tecnimed.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN IT-MF-000007598

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, Israel — 7 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
29UDI-DI device records
Class IIa 29
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 4 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
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
6 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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.

European Union29 raw hits, 0 excluded, 29 confirmed
United States4 registration records, 5 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: TECNIMED S.R.L.

Regulatory identity

EU manufacturer SRN
IT-MF-000007598
UK responsible person
Advena Ltd

Company information

Country
Italy
City
Vedano Olona (VA)
Website
www.tecnimed.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testingHome & self-testing

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.

Business registration

LEI
894500ON6QEGFU9B4A39
Registration status
Active
Legal form
Società A Responsabilità Limitata (SRL)
Incorporated
1976-07-01
Registered address
PIAZZALE COCCHI 12, VEDANO OLONA, 21040
Registration authority
Business Register, no. 00767900129
Registry record updated
2026-05-22

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004 · K033790
12007 · K072108
12013 · K122412
12014 · DEN130019
12017 · K160680

FDA listed device types

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch 1Continuous Measurement Thermometer 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08022386064065VisioFocusClass IIa
EU08022386000131Mousti-ClickClass IIa
EU08022386060234Zanza-ClickClass IIa
EU08022386064096VisioFocusClass IIa
UK17888infrared non contact thermometer VisioFocus familyClass IIa
UK59437Piezoelectric device for the treatment of mosquito bitesClass IIa
USK160680VisioFocus Mini, VisioFocus Smart2017-04-19
USDEN130019ZANZA-CLICK2014-11-07
USK122412VISIOFOCUS2013-03-13

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