Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013960814

FEI Number

3013960814

Entity Name

ABIONIC SA

City/State/Country

Epalinges Vaud, CH

Establishment Address

Biopole, Building Alanine, Route de la Corniche 5, Epalinges Vaud CH-1066, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Abionic SA (Owner Number: 10055862)

Owner / Operator Contact Address

Biopole, Alanine Building, Route de la Corniche 5, Epalinges, CH-NOTA CH-1066, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AbioSCOPE, IVD CAPSULE Aeroallergens I

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUW	System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens	Immunology	Class 2	866.5750	2017-10-13

Official Correspondent

No official correspondent registered.

US Agent Details

Yuan Xu Email: Yuan@focus42llc.com Phone: (919) 3603488

Related Public Records

Same Entity

Abionic SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013960814. Last updated year: 2026. Please use registration number 3013960814 when referencing this establishment in official correspondence.