HomeUnited Kingdom of Great Britain and Northern IrelandAMPLIVOX LIMITED

AMPLIVOX LIMITED

United Kingdom of Great Britain and Northern Ireland · Birmingham
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States4 registration records, 3 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: AMPLIVOX LTD · AMPLIVOX LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Birmingham

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Company number
01003695
Registration status
Active
Legal form
Private Limited Company
Incorporated
1971-03-02
Principal activity
28990 - Manufacture of other special-purpose machinery n.e.c.
Registered address
GENEVA HOUSE INTERNATIONAL PARK, BIRMINGHAM, B37 7GN

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12008 · K081841
12015 · K150163
12017 · K171265

FDA listed device types

Tympanometer 1Tester, Auditory Impedance 1Audiometer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171265Otowave 302 Portable Tympanometer2017-07-28
USK150163Otowave 202 Portable Tympanometer2015-04-23
USK081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER2008-07-16
BR10372700063Audiômetro de Diagnóstico AmplivoxClass II
BR10372700064TIMPANOMETRO AMPLIVOXClass II

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