Fidia Farmaceutici S.p.A.
IT-MF-000026988 · Italy · Abano Terme (PD)
Fidia Farmaceutici S.p.A. is registered in the European database on medical devices as a manufacturer, with 141 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 69 |
|---|---|
| Class IIb | 35 |
| Class IIa | 37 |
Most frequent device types declared: AQ1411_1B, AQ1412_1A, AQA9-06-2A, AQA9-07-1B, EQ0301_1A.
Among these devices, 100 are declared sterile, 42 implantable, 3 active.
Devices declared under this manufacturer
- BLUYAL MONODOSE
- DERMATOP HEALING CREAM PLUS
- FIDIALEYE NORM
- HYAL SYSTEM LIP
- HYALO4 CARE CREAM PLUS
- HYALO4 SKIN
- HYALO4 START
- HYALONE
- HYDEAL CYST
- HYMOVIS ONE
- REPLASYN
- RYM CICATRIZANTE
Showing 12 of 141 declared devices.
Catalogue references include 10000402, 10000823, 10001202, 10001289, 13001234, 13001262.
European nomenclature codes declared: P900402, Q0299, M040499, Q02030206, M0599, M9002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FIDIA FARMACEUTICI S.P.A (IT) · FDA 3017870985 |
| Devices in EUDAMED | 141 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FIDIA FARMACEUTICI S.P.A. |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 6 |
| Class 3 devices | 1 |
| Class 4 devices | 1 |
| First licensed | 2001-06-29 |
Licence types: Single Device (6), Device Family (1), Device Group (1).
Licensed under: HYALGAN, BIOSKIN, BIONECT PLUS CREAM, BIONECT PLUS GAUZE PADS, HYALOSILVER WOUND SPRAY, NEOVISC.
North American profile: Both markets. Fidia Farmaceutici S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
40052 | supplemented | 2029-10-24 |