HomeGermanyDEGUDENT GMBH

DEGUDENT GMBH

Germany · Hanau-Wolfgang
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
8listed device types
Class I 1Class II 7Class III 0
plus 27 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class II 18
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
24active device licences
Class II 3Class III 21
48 including historic records
TWTaiwanTFDA
31valid device licences
Class II 31
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIa 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
29active registrations
Class 1 2Class 2a 27
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 States27 registration records, 0 510(k), 0 PMA
Brazil18 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada24 confirmed, 0 excluded
Manufacturer names merged into this page: DEGUDENT GMBH

Company information

Country
Germany
City
Hanau-Wolfgang

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

Resin, Denture, Relining, Repairing, Rebasing 1Alloy, Metal, Base 1Dental Abutment Design Software For Dental Laboratory 1Alloy, Gold-Based Noble Metal 1Abutment, Implant, Dental, Endosseous 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80745409007CEREC TESSERA STARTER KITClass II
BR80196880207FAMÍLIA DE LIGAS DE CROMO-COBALTOClass II
BR80745409044Cercon® yo MLClass II
CA62960ALLCERAMClass III
CA62966DUCERAM SMLClass III
CA62967DUCERAM SMHClass III

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