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Phonic Ear, Inc.

Canada · Mississauga

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 3 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

31510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

3active device licences

Class II 3

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States0 registration records, 31 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: PHONIC EAR LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K043090	EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS	2004-12-23
US	K974658	INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT	1998-02-25
US	K974287	FM RECEIVER - AUDITORY TRAINER	1998-02-10
CA	60210	BEHIND-THE-EAR (BTE) HEARING AID - FM SYSTEM	Class II
CA	60211	ASSISTIVE LISTENING DEVICE - FM RECEIVER	Class II
CA	60338	ASSISTIVE LISTENING DEVICE - TRANSMITTER	Class II

Phonic Ear, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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