Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027487235

FEI Number

3027487235

Entity Name

Sonova North American Operations Center S.A.de C.V

City/State/Country

Mexicali Baja California, MX

Establishment Address

Avenida Riba 775, Parque Industrial Condesa, Mexicali Baja California CP 21395, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sonova AG (Owner Number: 9028479)

Owner / Operator Contact Address

Laubisruetistrasse 28, Staefa, CH-ZH 8712, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AudioNova T Phonak Virto M Vista T Phonak Virto P DX Insera Insera B Vista DX Au 3 T Insera EasyView Otoblock ampli-mini I 5P CIC-10 NWL PH Insera S-10 NW O MEMINI I 5P CIC-10 NWL PH Phonak Virto I Phonak Target Aura:fit AudioNova Lyric SoundLync kit Unitron TrueFit Lyric sizing and fitting kit Relate3.1 Titanium FitGuide AudioNova DX Phonak Lyric4 RELATE 2 Vista B Relate5 ITE 10 NW O AudioNova B Star Eclipse Roger 20 Roger 21 Unitron Shine Rev Au Basic+ Aura:fit Relate Lyric programming wand Aura:fit Lyric insertion tool

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2006-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

Syed Farhan Business: SONOVA USA INC Email: syed.farhan@sonova.com Phone: (331) 2781926

Related Public Records

Same Entity

Sonova AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002808415	Unitron Hearing, a division of National Hearing Services Inc.	KITCHENER Ontario, CA
3008848788	Sonova USA Inc.	Aurora, IL, US
3006312495	Sonova Operations Center Vietnam Company Ltd	Ho Chi Minh City, VN
3004929038	Sonova Hearing (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3005085999	Sonova AG	STAEFA Zurich, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027487235. Last updated year: 2026. Please use registration number 3027487235 when referencing this establishment in official correspondence.