HomeItalyBIOLOREN SRL

BIOLOREN SRL

Italy · Saronno Varese
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia — 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
6listed device types
Class I 3Class II 3Class III 0
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 1Class II 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States7 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil6 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: BIOLOREN SRL · BIOLOREN S.R.L. · Bioloren S.r.l.

Company information

Country
Italy
City
Saronno Varese

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

Drill, Dental, Intraoral 1Post, Root Canal 1Scissors, Surgical Tissue, Dental 1Crown And Bridge, Temporary, Resin 1Material, Tooth Shade, Resin 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81361440036Fita InFibra BiolorenClass II
BR81361440014Avant Fiber PostClass II
BR81361440031Trilor FiberClass II
SAME0000007008SFDAA00001VOCA-DENT TRANSLUCENT FIBER POSTS CONINAL
SAME0000007280SFDAA00001VOCA-DENT CONICAL DRILL

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