HomeGermanyDMG DIGITAL ENTERPRISES SE

DMG DIGITAL ENTERPRISES SE

Germany · Hamburg
✓ 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
7listed device types
Class I 5Class II 1Class III 0unclassified 1
plus 6 registration records and 1 510(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
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
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 States6 registration records, 1 510(k), 0 PMA, 7 excluded
Brazil6 confirmed, 6 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: DMG DIGITAL ENTERPRISES SE · DMG DIGITAL ENTERPRISE SE
Same-named companies — This database also contains companies with near-identical names: DMG DIGITAL ENTERPRISE SE. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Hamburg

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

12021 · K210940

FDA listed device types

Resin, Denture, Relining, Repairing, Rebasing 1Mouthguard, Prescription 1Indirect Bonding Tray 1Maintainer, Space Preformed, Orthodontic 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Medical Device Data System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK210940LuxaPrint Ortho Plus2021-09-03
BR10346419013LuxaPrint Ortho Comfort NXClass II
BR10346419014LuxaPrint Ortho Flex NXClass II
BR10346419015LuxaPrint Ortho NXClass II

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