Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005672861

FEI Number

3005672861

Entity Name

SWISSTRONICS CONTRACT MANUFACTURING AG

City/State/Country

Bronschhofen Sankt Gallen, CH

Establishment Address

Gebenloostrasse 15, Bronschhofen Sankt Gallen 9552, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Swisstronics Contract Manufacturing AG (Owner Number: 10047603)

Owner / Operator Contact Address

Gebenloostrasse 15, Bronschhofen, CH-SG 9552, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Genio®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2025-08-25

Official Correspondent

Robin Senn

US Agent Details

Richard Elbert Business: CICOR AMERICAS INC. Email: info-americas@cicor.com Phone: (617) 5762005

Related Public Records

Same Entity

Swisstronics Contract Manufacturing 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-0040-2025	Inspire Medical Systems Inc.	3	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Z-0041-2025	Inspire Medical Systems Inc.	3	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

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3008851924	PRONAT INDUSTRIES LTD.	Emek Hefer Ind. Park Haifa, IL
3030384402	NYXOAH INC	Summit, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005672861. Last updated year: 2026. Please use registration number 3005672861 when referencing this establishment in official correspondence.