FDA Registration
Active
🇮🇹 Italy
Platelet and plasma separator for bone graft handling
Reg #: 3006994492
·
FEI: 3006994492
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INDUSTRIA FARMECEUTICA GALENICA SENESE S.R.L.
- Registration Number
- 3006994492
- FEI Number
- 3006994492
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Cassia Nord 351
- City
- Monteroni d'Arbia Siena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- BK150294
Owner / Operator
- Firm Name
- Industria Farmeceutica Galenica Senese S.r.l.
- Operator Number
- 10051851
- Address
- Via Cassia Nord 351
- City
- Monteroni d'Arbia
- State
- Siena
- Postal Code
- 53014
- Country
- IT
- Correspondent
- Danila Antonia Perillo
US Agent
- Business Name
- DemosGlobal Inc.
- Contact Name
- Demos Global Group Inc. Demos Global Group Inc.
- Address
- 8950 SW 74 Court, Suite 1406
- City
- Miami
- State
- FL
- ZIP
- 33156
- Country
- US
- [email protected]
- Phone
- 305 6700979
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2016-05-11 |
Proprietary Names
Platelet and plasma separator for bone graft handling
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)