WYON AG

FDA Device Registration & Listing · Appenzell Steinegg Appenzell Innerrhoden, CH · Registration 3012654499

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012654499
FEI Number
3012654499
Entity Name
WYON AG
City/State/Country
Appenzell Steinegg Appenzell Innerrhoden, CH
Establishment Address
Saegehueslistrasse 15, Appenzell Steinegg Appenzell Innerrhoden 9050, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Wyon AG (Owner Number: 10092061)
Owner / Operator Contact Address
Saegehueslistrasse 15, Appenzell Steinegg, CH-AI 9050, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nucleus® 24 Cochlear Implant System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MCM Implant, Cochlear Unknown Class 3 N/A 2024-11-29
MHE Implant, Auditory Brainstem Unknown Class 3 N/A 2024-11-29

Official Correspondent

Armin Manser

US Agent Details

Lance Johnson Email: Lance@LDJCG.com Phone: (512) 7757610

Related Public Records

Same Entity

Wyon AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2012 Cochlear Americas Inc. 3
Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05 Advanced Bionics 3
Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

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3009092818 Cochlear Ltd Macquarie University New South Wales, AU
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012654499. Last updated year: 2026. Please use registration number 3012654499 when referencing this establishment in official correspondence.
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