FDA Registration
Active
🇹🇳 Tunisia
Bieffe Medital Manufacturing Oued Ellil Tunisia
Reg #: 3006755813
·
FEI: 3006755813
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Bieffe Medital Manufacturing Oued Ellil Tunisia
- Registration Number
- 3006755813
- FEI Number
- 3006755813
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Route de chebbaou
- City
- Oued Ellil Manouba
- Country
- TN
Regulatory Submissions
- 510(k) Number
- K102936
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
- Vantive US Healthcare LLC
- 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 |
|---|---|---|---|---|---|
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2020-04-01 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2006-11-22 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2021-03-12 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2021-03-12 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2021-03-12 |
Proprietary Names
Homechoice
Integrated APD Set with Cassette 3-prong
Automated PD Set with Cassette 4-Prong
Low Recirculation Volume APD Set with Cassette
HomeChoice PRO Automated Personal Cycler
Hospal Bloodlines
U9000 Ultrafilter
AK 98 Dialysis Machine
C-705 Accessory Expansion Chamber
Gambro Bloodlines
Establishment Types
Manufacture Medical Device