Vantive Health GmbH
CH-MF-000038981 · Switzerland · Opfikon
Vantive Health GmbH is registered in the European database on medical devices as a manufacturer, with 252 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 219 |
|---|---|
| Class IIa | 29 |
| Class I | 4 |
Most frequent device types declared: 5CGM02, 5CGM03, 5CGM21, 955549, 955599.
Among these devices, 51 are declared sterile, 24 active, 8 with a measuring function.
Authorised representative in the Union: Vantive S.r.l..
Devices declared under this manufacturer
- AK 98
- BiCart 1250
- BiCart 650
- BiCart Select combi-pak
- CWP 100
- FlexiCap Disconnect Cap with Povidone-Iodine Solution
- Nephral ST
- POLYFLUX 14 L
- POLYFLUX 170 H
- POLYFLUX 210 H
- SelectBag
- SoftPac
Showing 12 of 252 declared devices.
Catalogue references include 112631, 114959, 115763, 955516MDR, 956014, Polyflux 14L.
European nomenclature codes declared: F040101, F01060303, F040201, Z12099007, F020280, F010604.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Vantive Health GmbH (CH) · FDA 3033903155 |
| Devices in EUDAMED | 252 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 252 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 3.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | VANTIVE HEALTH GMBH |
What it holds in Canada
| Licences on record | 20 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 15 |
| First licensed | 2000-12-13 |
Licence types: Device Family (8), Device Group Family (4), Single Device (4), Device Group (2).
Licensed under: GAMCATH CATHETERS, POLYFLUX, NEPHRAL ST, PRISMAFLEX SETS: HF 1000/HF 1400, PRISMAFLEX HAEMODIALYSIS SETS WITH FILTER, PRISMAFLEX - EXTRACORPOREAL FILTER CIRCUITS.
North American profile: Both markets. Vantive Health GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 123153 0023 | issued | 2028-01-09 |
G15 123153 0024 | issued | 2028-01-11 |
G12 123153 0018 | issued | 2029-12-18 |
G12 123153 0017 | issued | 2030-01-30 |