FDA Registration
Active
🇮🇹 Italy
Lexa MINI (RIS-303, RIS-305)
Reg #: 3003947740
·
FEI: 3003947740
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- W&H STERILIZATION S.R.L.
- Registration Number
- 3003947740
- FEI Number
- 3003947740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VIA BOLGARA, 2
- City
- BRUSAPORTO Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K223858
Owner / Operator
- Firm Name
- W&H STERILIZATION S.R.L.
- Operator Number
- 9056923
- Address
- Via Bolgara, 2
- City
- Brusaporto
- State
- Bergamo
- Postal Code
- I-24060
- Country
- IT
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2023-07-28 |
Proprietary Names
Lexa MINI (RIS-303, RIS-305)
Establishment Types
Manufacture Medical Device