HomeItalyORTHODONTIC MANUFACTURER SIA SRL

ORTHODONTIC MANUFACTURER SIA SRL

Italy · Rocca D Evandro Caserta
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, Russia — 5 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
15listed device types
Class I 14Class II 1Class III 0
plus 15 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States15 registration records, 0 510(k), 0 PMA, 11 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 1 excluded
Manufacturer names merged into this page: ORTHODONTIC MANUFACTURER SIA SRL

Company information

Country
Italy
City
Rocca D Evandro Caserta

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 15
Spring, Orthodontic 1Pusher, Band, Orthodontic 1Maintainer, Space Preformed, Orthodontic 1Band, Preformed, Orthodontic 1Facebow 1Clamp, Wire, Orthodontic 1Tube, Orthodontic 1Plier, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000001093SFDAA00050FULLY-ADJUSTABLE FACEMASK

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