pro3dure medical GmbH
DE-MF-000000024 · Germany · Iserlohn
pro3dure medical GmbH is registered in the European database on medical devices as a manufacturer, with 379 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 379 |
|---|
Most frequent device types declared: 12090101, 12090102, 12090104, 12090202, 12090203.
Devices declared under this manufacturer
- Hand Pour Resin PR-1
- SysTherm PU
- THERMEO Powder
- THERMEO SO
- Temporary Crown & Teeth
- UCAN PRINT BASE
- audioprint GR-10
- audioprint GR-11
- audioprint HPR-1
- dima Print Denture Base 2
- dima Print Denture Teeth 2
- otosil ES-1.1
Showing 12 of 379 declared devices.
Catalogue references include 66100850, 768345, A0033004, A1000502, A1000753, A1000885.
European nomenclature codes declared: Q010699, Y214580, Y214599, Q030499, Q0102050101, Q01020605.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PRO3DURE MEDICAL GMBH (DE) · FDA 3014888923 |
| Devices in EUDAMED | 379 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PRO3DURE MEDICAL GMBH |
What it holds in Canada
| Licences on record | 9 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 9 |
| First licensed | 2021-12-22 |
Licence types: Device Family (7), System (1), Single Device (1).
Licensed under: THERMEO SYSTEM, PRINTODENT GR-22 FLEX, PRINTODENT GR-14.1 DENTURE & PRINTODENT GR-14., PRINTODENT GR-17 TEMPORARY & PRINTODENT GR-17., PRINTODENT GR-10 GUIDE, PRINTODENT GR-19 OA.
North American profile: Both markets. pro3dure medical GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911221079 | issued | 2031-01-25 |