This page includes the latest FDA filings for Abionic S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013960814 | ||||||
| FEI Number | 3013960814 | ||||||
| Name | Yuan Xu | ||||||
| Owner & Operator | Abionic SA | ||||||
| Contact Address | Biopole, sect. Esplanade SE-B Route de la Corniche 5 Epalinges CH-NOTA CH-1066 CH | ||||||
| US Agent | |||||||
| Importing Logistics Registration |
| ||||||
| Registration Status | 1 | ||||||
| Initial Importer | N | ||||||
| Registration Expiration | 2020-04-25 | ||||||
| Registration Address | 292 Linden Park Lane Cary, NC 27519 US | ||||||
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| Abionic SA | abioSCOPE Control | 2025-10-07 |
| Abionic SA | IVD CAPSULE Control PSP | 2025-10-07 |
| Abionic SA | IVD CAPSULE PSP | 2025-02-26 |
| Abionic SA | abioSCOPE | 2025-02-26 |
Yuan Xu [Abionic SA] | abioSCOPE, IVD CAPSULE Aeroallergens I | 2017-10-13 |
| NCAGE Code | SFNX7 | ABIONIC SA |
| CAGE Code | SFNX7 | ABIONIC SA |
| S.A.M. Registration | SFNX7 [485727270] | ABIONIC SA |