Gebr. Brasseler GmbH & Co. KG
DE-MF-000006446 · Germany · Lemgo
Gebr. Brasseler GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 169 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 169 |
|---|
Among these devices, 163 are declared sterile.
Catalogue references include 54780067, 54780072, 54780115, 54780116, 54780119, H133.314.010.R0.
European nomenclature codes declared: Q010199, L090999, V0199, S010401.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GEBR. BRASSELER GMBH & CO. KG (DE) · FDA 8010468 |
| Devices in EUDAMED | 169 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 73 |
|---|---|
| Found in the U.S. device database | 73 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GEBR. BRASSELER GMBH & CO KG |
What it holds in Canada
| Licences on record | 28 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 27 |
| Class 3 devices | 1 |
| First licensed | 2006-10-27 |
Licence types: Device Family (28).
Licensed under: BURS, ROOT POST FIBRE REINFORCED COMPOSITE, DENTAL DIAMOND INSTRUMENTS, BURS, DENTAL, DENTAL BURS - TUNGSTEN CARBIDE, CERAMIC BURS, DENTAL.
North American profile: Both markets. Gebr. Brasseler GmbH & Co. KG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1470094-1 | supplemented | 2026-02-28 |
HZ 1470094-1 | supplemented | 2031-02-28 |