HomeItalyMectronic Medicale srl

Mectronic Medicale srl

Italy · Grassobbio (BG) · www.mecmedix.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN IT-MF-000040989

This company has registrations in European Union, United States, Brazil, Taiwan, Singapore, Australia, Russia — 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
20UDI-DI device records
Class IIa 1Class IIb 19
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class II 4Class III 1
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 1IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2a 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.

European Union20 raw hits, 0 excluded, 20 confirmed
United States3 registration records, 2 510(k), 0 PMA
Manufacturer names merged into this page: MECTRONIC MEDICALE S.R.L.

Regulatory identity

EU manufacturer SRN
IT-MF-000040989

Company information

Country
Italy
City
Grassobbio (BG)
Website
www.mecmedix.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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

Legal name
MECTRONIC MEDICALE S.R.L.
LEI
8156001F8C0BC19E6B66
Registration status
Active
Legal form
Società A Responsabilità Limitata (SRL)
Incorporated
1996-01-10
Registered address
VIA ORIO AL SERIO, 15, GRASSOBBIO, 24050
Registration authority
Business Register, no. 02433980162
Registry record updated
2025-11-25

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

12019 · K183693
12023 · K221043

FDA listed device types

Massager, Vacuum, Radio Frequency Induced Heat 1Lamp, Infrared, Therapeutic Heating 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08051499971595ILUX SMART (2W 650nm)Class IIb
EU08051499970598ILUX SMART (open model)Class IIb
EU08051499974152ILUX SMART (20W 810+1064nm)Class IIb
EU08051499974145ILUX SMART (15W 810+1064nm)Class IIb
USK221043Doctor Tecar Plus, Doctor Tecar Smart2023-02-17
USK183693Doctor Tecar2019-02-22

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