Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021514

FEI Number

3003557127

Entity Name

WS Audiology A/S

City/State/Country

Lynge Hovedstaden, DK

Establishment Address

Nymoellevej 6, Lynge Hovedstaden DK-3540, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

WS Audiology Inc. (Owner Number: 8021514)

Owner / Operator Contact Address

Nymoellevej 6, Lynge, DK-84 DK-3540, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Widex Enjoy Widex Widex Allure Widex Magnify Widex CROS Widex Evoke Widex Enjoy Widex Magnify Widex Moment Widex Widex Evoke Widex Enjoy Widex Widex Magnify Widex Evoke

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2016-11-17
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2011-09-01
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2001-10-19

Official Correspondent

Isabel Restivo

US Agent Details

Isabel Restivo Business: WS Audiology Email: isabel.restivo@wsa.com Phone: (551) 5799581

Related Public Records

Same Entity

WS Audiology Inc.

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

View Entity Profile →

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

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3015965752	HANA MICROELECTRONICS (CAMBODIA) CO., LTD.	Koh Kong Province, KH
3030682076	ELEHEAR INC.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021514. Last updated year: 2026. Please use registration number 8021514 when referencing this establishment in official correspondence.