HomeItalyL.M. MEDICAL DIVISION S.R.L.

L.M. MEDICAL DIVISION S.R.L.

Italy
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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
108listed device types
Class I 19Class II 73Class III 16
plus 411 registration records and 31 510(k), 19 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class I 4Class II 13
47 including historic records
SASaudi ArabiaSFDA
27registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
98active device licences
Class II 38Class III 18Class IV 42
205 including historic records
TWTaiwanTFDA
5valid device licences
Class I 1Class II 4
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 4IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States411 registration records, 31 510(k), 19 PMA, 109 excluded
Brazil17 confirmed, 31 excluded
Saudi Arabia27 confirmed, 9 excluded
Canada98 confirmed, 74 excluded
Manufacturer names merged into this page: St. Jude Medical, Atrial Fibrillation Division, Inc. · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · St. Jude Medical, Cardiology Division, Inc. · CERAMTEC GmbH Medical Products Division · OHMEDA MEDICAL, A DIVISION OF DATEX OHMEDA INC. · ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION

Company information

Country
Italy

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

21980
11981
11982
31983
11984
11990
11997
11998
22005
12010
12012
12013
22015
12016
12017
22018
32019
12021
22022
12024

FDA listed device types

showing 8 of 108
Electrosurgical, Cutting & Coagulation & Accessories 1Disinfectant, Dialysate Delivery System 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Cannula, Catheter 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240827SET-50022024-05-24
USK221922Trinias2022-07-28
USK221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging System2022-07-01
BR10332340052CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803Class II
BR10175859017Gardian 25 mm - Filtro de SeringaClass II
BR10175859001Ultipor 25 Filtro para Sistema RespiratórioClass II
SAME0000009230SFDAA00001Kit, Water Trap, EtCO2, 3160
SAME0000004826SFDAA00011Pentax Laryngostroboscope
CA8476VACUUM REGULATORSClass II
CA8494PEDIACTRIC AEROSOL TENTClass II
CA8497INTERMITTENT SUCTION UNITClass II

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