Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043496923

FEI Number

3043496923

Entity Name

EARGYM LTD

City/State/Country

London London, City of, GB

Establishment Address

167 to 169 Great Portland Street, 5th Floor, London London, City of W1W 5PF, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

eargym Ltd (Owner Number: 10095290)

Owner / Operator Contact Address

167 TO 169 GREAT PORTLAND STREET, 5TH FLOOR, London, GB-LND W1W 5PF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eargym eargym

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2026-02-20
EPF	Hearing Aid, Group And Auditory Trainer	Ear, Nose, Throat	Class 2	874.3320	2026-02-19

Official Correspondent

Edwin Lindsay

US Agent Details

Edwin Lindsay Business: RAF Solutions Inc Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

eargym Ltd

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
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3005019184	Sivantos GmbH	Erlangen Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043496923. Last updated year: 2026. Please use registration number 3043496923 when referencing this establishment in official correspondence.