ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Thi Total Healthcare Innovation GmbH
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017300722 | 3017300722 | THI TOTAL HEALTHCARE INNOVATION GMBH | 1 | N | 2026-01-01 | Gewerbestrasse 4 Feistritz im Rosental Karnten AT 9181 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 09009607811003 | ViVi® HELMET25 - 81100 | 1-858-822-9433 | vincebates@ivysurgical.com |
| 09009607811010 | ViVi® HELMET25 XL - 81100XL | 1-858-822-9433 | vincebates@ivysurgical.com |
| 09009607811300 | ViVi® HELMET25 HPL - 81130 | 1-858-822-9433 | vincebates@ivysurgical.com |
| 09009607811317 | ViVi® HELMET25 XL HPL - 81130XL | 1-858-822-9433 | vincebates@ivysurgical.com |
| 09009607835207 | ViVi® PEEL-OFF TOGA PREMIUM XL-XXL - 82520V | 1-858-822-9433 | vincent.bates@thigmbh.at |
| 09009607835214 | ViVi® PEEL-OFF TOGA PREMIUM M-L - 82521V | 1-858-822-9433 | vincent.bates@thigmbh.at |
| 09009607835221 | ViVi® PEEL-OFF TOGA PREMIUM XXS-S - 82522V | 1-858-822-9433 | vincent.bates@thigmbh.at |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 321935 | 1263498098 | K243522 | ViVi® Toga Premium | FYA | 2025-05-30 |
| 321935 | 1496569986 | K222214 | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | FXY | 2023-10-17 |
| 321935 | 2060952166 |
Thi Total Healthcare Innovation GmbH
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