Abionic S A

FDA Filings

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.

FDA Registration(s)
Registration Number3013960814
FEI Number3013960814
NameYuan Xu
Owner & OperatorAbionic SA
Contact AddressBiopole, sect. Esplanade SE-B Route de la Corniche 5
Epalinges CH-NOTA CH-1066 CH
US Agent
Importing Logistics Registration
ImporterFocus 42, LLC
Address292 Linden Park Lane
Cary, NC 27519 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address292 Linden Park Lane
Cary, NC 27519 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Abionic SA
IVD CAPSULE PSP 2025-02-26
Abionic SA
abioSCOPE 2025-02-26
Yuan Xu [Abionic SA]
abioSCOPE, IVD CAPSULE Aeroallergens I2017-10-13

Related Finance Registrations
NCAGE CodeSFNX7ABIONIC SA
CAGE CodeSFNX7ABIONIC SA
S.A.M. RegistrationSFNX7 [485727270]ABIONIC SA

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