HomeItalyMICERIUM S.P.A.

MICERIUM S.P.A.

Italy · Avegno
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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
17listed device types
Class I 12Class II 5Class III 0
plus 17 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
1active device licences
Class II 1
7 including historic records
TWTaiwanTFDA
5valid device licences
Class I 3Class II 2
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
8active registrations
Class 2a 8
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 States17 registration records, 6 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: MICERIUM S.P.A.

Company information

Country
Italy
City
Avegno

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

32006 · K062355
12007 · K063170
12008 · K072978
12011 · K103474

FDA listed device types

showing 8 of 17
Curette, Periodontic 1Bur, Dental 1Disk, Abrasive 1Positioner, Tooth, Preformed 1Wheel, Polishing Agent 1Point, Abrasive 1Strip, Polishing Agent 1Toothbrush, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK103474ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)2011-02-07
USK072978TENDER ORTHO BOND-ENA BOND-ENA ETCH2008-01-17
USK063170TENDER FIBER2007-01-12
BR10336460111Temp Silicon BrushClass I
BR10336460083ENAMEL PLUS HRIClass II
CA72657TENDER FIBER ZEROClass II

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