surgebright GmbH
AT-MF-000002664 · Austria · Lichtenberg bei Linz
surgebright GmbH is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Among these devices, 4 are declared reusable.
Devices declared under this manufacturer
- Shark Screw® coupling
- Shark Screw® drill
- Shark Screw® driver acl
- Shark Screw® driver cut
- Shark Screw® driver ht
- Shark Screw® knob
- Shark Screw® tap
Showing 12 of 15 declared devices.
Catalogue references include SCDR35, SCDR45L, SCDR50L, SCDRVacl, SCDRVcut, SCTA35.
European nomenclature codes declared: L090901, L091001, H900399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SURGEBRIGHT GMBH (AT) · FDA 3027305775 |
| Devices in EUDAMED | 15 |
| Country of registration | Austria |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 60.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. surgebright GmbH is registered in the United States but was not found in the Canadian register.