FDA Registration
Active
🇮🇹 Italy
Bieffe Medital S.p.A.
Reg #: 3003591774
·
FEI: 3003591774
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- Bieffe Medital S.p.A.
- Registration Number
- 3003591774
- FEI Number
- 3003591774
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA STELVIO 94
- City
- SONDALO (SO) Sondrio
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K072908
Owner / Operator
- Firm Name
- Vantive US Healthcare LLC
- Operator Number
- 9038727
- Address
- 510 Lake Cook Road
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Jennifer Masek-Little
US Agent
- Business Name
- Baxter Healthcare Corporation
- Contact Name
- Jennifer Masek-Little
- Address
- 510 Lake Cook Rd
- City
- Deerfield
- State
- IL
- ZIP
- 60015
- Country
- US
- [email protected]
- Phone
- 815 3548549
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2008-05-18 |
Proprietary Names
PRISMASATE
PrismaSATE dialysis solutions
Establishment Types
Manufacture Medical Device