Scheftner GmbH
DE-MF-000049419 · Germany · Mainz
Scheftner GmbH is registered in the European database on medical devices as a manufacturer, with 180 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 180 |
|---|
Most frequent device types declared: CORiTEC CoCr Mo Disc, CoCrWMo powder, Mogucera C Disc, Starbond Easy Disc.
Among these devices, 158 are declared implantable.
Devices declared under this manufacturer
- Mogucera C Disc
- Novobond Easy Disc
- Starbond CoS Disc basic
- Starbond CoS Powder 16 (5 kg)
- Starbond CoS Powder 45
- Starbond Easy Disc
- Starbond Easy Powder 30+
- Starbond Ti4 Disc
- Starbond Ti4 Powder 45
- Starbond Ti5 Block
- Starbond Ti5 Disc
- Starbond Ti5 Powder 45
Showing 12 of 180 declared devices.
Catalogue references include 133718, 136513, 138018, 138116, MD135512, MD136512.
European nomenclature codes declared: Q010601.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SCHEFTNER GMBH (DE) · FDA 1000304307 |
| Devices in EUDAMED | 180 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 180 |
|---|---|
| Found in the U.S. device database | 101 |
| Share | 56.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SCHEFTNER GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2023-10-05 |
Licence types: Device Family (7).
Licensed under: STARBOND COS POWDER, STARBOND COS DISC BASIC, STARBOND EASY DISC, MODELSTAR S POWDER, STARBOND EASY POWDER AND I-PROMELT, STARBOND TI5 POWDER 45, TIPLADUR23, I-PROFUSE.
North American profile: Both markets. Scheftner GmbH is registered in both the United States and Canada.