HomeItalyLipogems International Spa

Lipogems International Spa

Italy · Milan · www.lipogems.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN IT-PR-000031482

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel, Russia — 8 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
24UDI-DI device records
Class IIa 24
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 6 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
BRBrazilANVISA
4registered devices
Class II 4
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 II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 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.

European Union24 raw hits, 0 excluded, 24 confirmed
United States6 registration records, 3 510(k), 0 PMA
United Kingdom1 confirmed, 0 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: LIPOGEMS INTERNATIONAL S.P.A. · LIPOGEMS INTERNATIONAL SPA

Regulatory identity

EU manufacturer SRN
IT-PR-000031482
UK responsible person
QCS International LTD.

Company information

Country
Italy
City
Milan
Website
www.lipogems.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
LIPOGEMS INTERNATIONAL S.P.A.
LEI
8156000EA85219095C09
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
2010-07-05
Registered address
VIALE BIANCA MARIA, 24, MILANO, 20129
Registration authority
Business Register, no. 07093190960
Registry record updated
2026-02-05

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

12014 · K142682
12016 · K161636
12017 · K171135

FDA listed device types

Lipoaspirate Washing System For Aesthetic Body Contouring 1System, Suction, Lipoplasty 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08058773563019Lipogems Procedural Kit Tray - Sport Medicine 240Class IIa
EU08058773563002Lipogems Procedural Kit Tray - Sport Medicine 120Class IIa
EU08058773562999Lipogems Procedural Kit Tray - Sport Medicine 60Class IIa
EU08058773562982Lipogems Procedural Kit Tray - Beauty 240Class IIa
UK56627Lipogems Process DeviceClass IIa
USK171135Lipogems System2017-05-18
USK161636Lipogems System2016-11-04
USK142682The Lipogems System2014-12-22
BR80696930013LIPOGEMS SYSTEM- ORTHOClass II
BR80696930016LIPOGEMS SYSTEM - BEAUTYClass II
BR80696930014LIPOGEMS SYSTEM – SPORT MEDICINEClass II

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