SCHÖLLY FIBEROPTIC GMBH
DE-MF-000005618 · Germany · Denzlingen
SCHÖLLY FIBEROPTIC GMBH is registered in the European database on medical devices as a manufacturer, with 198 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 198 |
|---|
Most frequent device types declared: Arthroscopes, Camera Control Units, Camera Heads, Cystoscopes, Fiberoptic Light Guides.
Among these devices, 2 are declared sterile, 46 active.
Devices declared under this manufacturer
- AlphaSMART
- AlphaScope
- BULKAMID ®
- EinsteinVision®
- SmartVue®
- UROLIFT ®
Showing 12 of 198 declared devices.
Catalogue references include 05-0094l-nir, 05.0085l, 05.0108z, 21.0008a, 31.0802a, PE641A.
European nomenclature codes declared: Z12029009, Z12020480, Z12021008, Z12020405, Z12020701, Z12021101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 198 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 198 |
|---|---|
| Found in the U.S. device database | 93 |
| Share | 47.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SCHÖLLY FIBEROPTIC GMBH |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 11 |
| First licensed | 2014-10-15 |
Licence types: Device Family (8), Single Device (3).
Licensed under: LAPAROSCOPES, URETERO-RENOSCOPE, CYSTOSCOPE, ARTHOSCOPES, NEPHROSCOPES, INSTRUMENT BRIDGE FOR NEPHROSCOPE.
North American profile: Canada only. SCHÖLLY FIBEROPTIC GMBH holds a Canadian licence but was not found in the U.S. register.