HomeGermanyINDIGODENTAL GMBH.

INDIGODENTAL GMBH.

Germany · Pinneberg Schleswig-Holstein
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
13listed device types
Class I 4Class II 8Class III 0unclassified 1
plus 26 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 1Class II 7
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States26 registration records, 0 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: indigodental GmbH · INDIGODENTAL GMBH.

Company information

Country
Germany
City
Pinneberg Schleswig-Holstein

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 13
Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Material, Impression 1Crown And Bridge, Temporary, Resin 1Agent, Tooth Bonding, Resin 1Coating, Filling Material, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10352040035MegagelClass II
BR10352040028MEGALINK ESTHETICClass II
BR10352040032MEGALINK TRY-INClass I

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