Mastelli S.r.l.
IT-MF-000023613 · Italy · Bussana
Mastelli S.r.l. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 28 |
|---|
Most frequent device types declared: RDM11BLA20XS, RDM60BLS20XS, RDM62BLS20XS.
Among these devices, 26 are declared sterile, 22 implantable.
Devices declared under this manufacturer
- Condrotide
- Condrotide HA
- Ialest
- Newest
- Newgyn
- Nucliaskin Oral Care
- Nucliaskin S
- Plinest Fast
- Plinest Hair
- Plinest One
- PolyPhil
- PolyPhil eye
Showing 12 of 28 declared devices.
Catalogue references include DDM02TU30XC, DDM20BL20WE1, DDM21EBL20WE1, DDM21HBL20WE1, DDM22BL20XS, DDM30V20.
European nomenclature codes declared: P900402, Q0199, U0803, M9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 28 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| 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. Mastelli S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.26/6122 | issued | 2030-07-10 |
EPT 0477.MDR.26/6121 | issued | 2031-03-29 |
EPT 0477.MDR.26/6120 | issued | 2030-07-10 |
EPT 0477.MDR.26/6119 | issued | 2031-03-29 |
CVD006326 | issued | 2031-06-25 |
CSQ003726 | issued | 2031-06-25 |