DETAX GmbH
DE-MF-000022666 · Germany · Ettlingen
DETAX GmbH is registered in the European database on medical devices as a manufacturer, with 267 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 267 |
|---|
Most frequent device types declared: Adhesives, Brand names, Colour Variants, Colour variants, Colour variants, different Brand names.
Among these devices, 36 are declared implantable.
Devices declared under this manufacturer
- Freeprint crown A2 500g
- Freeprint crown D3 500g
- Lack L nano, 100 ml
- Primeprint Splint SF 1.000 g
- Ultraprint-Dental Denture UV 500 g
- VITA VIONIC BASE RESIN IMPACT pink
- egger LP/H Lack antibac, hart, 30 ml
- egger LP/HS blau 300g, schlagzäh
- egger LP/W Lack, weich, 100 ml
- egger LP/W Lack, weich, 30 ml
- smartrepair A2
- tempofit duomix A2 Eco-Pack.
Showing 12 of 267 declared devices.
Catalogue references include 02209, 02270, 02378, 02783, 02800, 04416.
European nomenclature codes declared: Q030499, Q0102050199, Q0102050101, Q010499, Q0101010203, Q01020199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DETAX GMBH (DE) · FDA 9680954 |
| Devices in EUDAMED | 267 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DETAX GMBH |
What it holds in Canada
| Licences on record | 16 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 1 |
| First licensed | 2006-06-26 |
Licence types: Device Family (10), System (5), Single Device (1).
Licensed under: TEMPOFIT, MOLLOPLAST B, MOLLOSIL PLUS, MOLLOSIL (RELINING MATERIAL), IMPLANTLINK SEMI, FREEFORM.
North American profile: Both markets. DETAX GmbH is registered in both the United States and Canada.