HomeGermanyPRO3DURE MEDICAL GMBH

PRO3DURE MEDICAL GMBH

Germany · Iserlohn
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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
11listed device types
Class I 7Class II 3Class III 0unclassified 1
plus 11 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
9 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 States11 registration records, 5 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: PRO3DURE MEDICAL GMBH

Company information

Country
Germany
City
Iserlohn

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

12020 · K201827
22021 · K211415
12022 · K212017
12024 · K231775

FDA listed device types

showing 8 of 11
Plate, Base, Shellac 1Maintainer, Space Preformed, Orthodontic 1Positioner, Tooth, Preformed 1Kit, Earmold, Impression 1Hearing Aid, Air-Conduction, Prescription 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231775GR Resin System MSI2024-08-08
USK212017Thermeo System2022-04-08
USK211415GR Splint Resin System2021-10-21
BR10166849015DIMA PRINT SPLINT CLEARClass II
BR10166849017Dima Print Denture Base 2Class II

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