Floy GmbH
DE-MF-000016503 · Germany · München
Floy GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: FloyBoneClassification, FloyBrain, FloyMammo, FloyOsteo.
Among these devices, 11 are declared active.
Devices declared under this manufacturer
- FloyBoneClassification
- FloyBrain
- FloyMammo
- FloyOsteo
- Signal BMD
- Signal CT Abdomen
- Signal Knee
- Signal MR Abdomen
- Signal MR BMD
- Signal MR Head
- Signal MR Shoulder
Catalogue references include Floy Signal, FloyBoneClassification, FloyBrain, FloyMammo, FloyOsteo, Signal CT Abdomen.
European nomenclature codes declared: Z11039092, Z11030592.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 11 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Floy GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
SCAR-7.2.1.4 | amended | 2030-09-29 |
HZ 2369288-1 | cancelled | 2028-07-11 |