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OTICON, INC.

USA · Somerset

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 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

4listed device types

Class I 2Class II 2Class III 0

plus 4 registration records and 66 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States4 registration records, 66 510(k), 0 PMA, 4 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: OTICON, INC. · Oticon AS

FDA 510(k) clearances by year

31978

31979

61980

61981

21982

11983

31984

41985

71986

51987

11988

41989

61990

41992

21993

31995

41996

21997

FDA listed device types

Face Plate Hearing Aid 1Hearing Aid, Air-Conduction, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Masker, Tinnitus 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K973885	OTICON DIGISOUND ITE	1997-11-04
US	K973886	OTICON DIGISOUND COMPACT	1997-11-04
US	K964683	DIGIFOCUS ITE	1996-12-12
SA	ME0000016349SFDAA00018	Oticon Medical Streamer	—

OTICON, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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