FLUORON GmbH
DE-MF-000009235 · Germany · Ulm
FLUORON GmbH is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 12 are declared sterile, 8 implantable.
Devices declared under this manufacturer
- Brilliant Peel
- Brilliant Peel Dual Dye
- F-Decalin - Syringe 5 ml
- F-Decalin - Syringe 7 ml
- F-Decalin - Vial 5 ml
- F-Decalin - Vial 7 ml
- F-Octane - Syringe 5 ml
- F-Octane - Syringe 7 ml
- F-Octane - Vial 5 ml
- F-Octane - Vial 7 ml
- F4H5 WashOut
- Vioron
Catalogue references include G-80107, G-80115, G-80117, G-80305, G-80307, G-80317.
European nomenclature codes declared: Q02030205, Q02030201, Q02030299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FLUORON GMBH |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 4 |
| First licensed | 2000-12-13 |
Licence types: Single Device (4), Device Family (2).
Licensed under: PERFLUORCARBON (PFCLS), DENSIRON 68, SILICONE OIL, EASYGAS SF6, DENSIRON XTRA, F4H5 WASHOUT.
North American profile: Canada only. FLUORON GmbH holds a Canadian licence but was not found in the U.S. register.