FDA Registration
Active
🇨🇭 Switzerland
Vantive Health GmbH
Reg #: 3033903155
·
FEI: 3033903155
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Vantive Health GmbH
- Registration Number
- 3033903155
- FEI Number
- 3033903155
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Thurgauerstrasse 130
- City
- Glattpark (Opfikon) Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K082758
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 |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2024-12-11 |
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2025-12-17 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2019-09-06 |
Proprietary Names
Tipstop
PRISMAFLO
PrisMax System Version 2
TherMax
Establishment Types
Export Device to the United States But Perform No Other Operation on Device