Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003138182

FEI Number

3003138182

Entity Name

AMPLIVOX LTD

City/State/Country

Birmingham, GB

Establishment Address

Geneva House, International Park, Starley Way, Birmingham B37 7GN, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Amplivox Ltd (Owner Number: 10026506)

Owner / Operator Contact Address

Geneva House, International Park, Starley Way, Birmingham, GB-NOTA B37 7GN, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Otowave Otowave 302 Otowave 302+ Otowave 102-C Amplivox PC850 Amplivox Otosure Amplivox CA850 Amplivox 270+ modelONE Amplivox 270 Amplivox 240 Amplivox 260 Amplivox 170 Amplivox 116

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2008-07-23
ETY	Tester, Auditory Impedance	Ear, Nose, Throat	Class 2	874.1090	2017-08-01
NAS	Tympanometer	Ear, Nose, Throat	Class 2	874.1090	2017-08-01
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2008-07-23

Official Correspondent

No official correspondent registered.

US Agent Details

Brandon Bell Email: bnbl@e3diagnostics.com Phone: (952) 9476097

Related Public Records

Same Entity

Amplivox 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
K833045	American Electromedics Corp.	CLINICAL TYMPANOMETER	1983-12-08
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
9710051	INTERACOUSTICS A/S	Middelfart Syddanmark, DK
3011310592	DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, PL
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK
3002504821	MAICO Diagnostics GmbH	Berlin, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003138182. Last updated year: 2026. Please use registration number 3003138182 when referencing this establishment in official correspondence.