FDA Registration
Active
🇮🇹 Italy
G21 S.R.L.
Reg #: 3021566676
·
FEI: 3021566676
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- STEROX SRL
- Registration Number
- 3021566676
- FEI Number
- 3021566676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via di Botriolo, 198
- City
- Castelfranco Piandisco Arezzo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K202338
Owner / Operator
- Firm Name
- STEROX SRL
- Operator Number
- 10084103
- Address
- via galvani 9/G
- City
- Spresiano
- State
- Treviso
- Postal Code
- 31027
- Country
- IT
- Correspondent
- Mario Pavan
US Agent
- Business Name
- Pangea Export USA LLC
- Contact Name
- Caterina Zimmerman
- Address
- 8383 Wilshire Blvd. Ste. 800
- City
- Beverly Hills
- State
- CA
- ZIP
- 90211
- Country
- US
- [email protected]
- Phone
- 415 2506061
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2022-01-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-01-26 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-01-26 |
Proprietary Names
G21 S.R.L.
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)