HomeItalyMEDESY srl

MEDESY srl

Italy · Maniago Pordenone
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, 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
pendingnot queried
USUnited StatesFDA openFDA
33listed device types
Class I 32Class II 1Class III 0
plus 33 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 9Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
11registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
7active registrations
Class 2a 7
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 States33 registration records, 0 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Saudi Arabia11 confirmed, 1 excluded
Manufacturer names merged into this page: MEDESY srl · MEDESY SRL

Company information

Country
Italy
City
Maniago Pordenone

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 listed device types

showing 8 of 33
Carrier, Amalgam, Operative 1Forceps 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Handle, Scalpel 1Forceps, Articulation Paper 1Accessories, Implant, Dental, Endosseous 1Elevator, Surgical, Dental 1Chisel, Osteotome, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80080580001INSTRUMENTAL ODONTOLÓGICO ARTICULADO NÃO CORTANTE MEDESYClass I
BR80080580003INSTRUMENTAL ODONTOLÓGICO NÃO ARTICULADO CORTANTE MEDESYClass II
BR80080580004INSTRUMENTAL ODONTOLÓGICO MEDESYClass I
SAME0000001282SFDAA00009MEDESY TWEEZERS
SAME0000001537SFDAA00008MEDESY MODELLING INSTRUMENTS

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