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Oticon Medical AB

Sweden · Askim

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 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

6listed device types

Class I 2Class II 4Class III 0

plus 16 registration records and 16 510(k), 14 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 3Class III 5

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

30active ARTG entries

Class I 19Class III 3IIa 5IIb 1Class Im (measuring) 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 3 1

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 States16 registration records, 16 510(k), 14 PMA, 5 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: Oticon Medical AB · OTICON MEDICAL AB · OTICON MEDICAL · OTICON MEDICAL / NEURELEC SAS

FDA 510(k) clearances by year

12008

12009

22011

12012

12013

12014

22015

22016

12019

32021

12024

FDA listed device types

Hearing Aid, Bone Conduction 1Active Implantable Bone Conduction Hearing System 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Hearing Aid, Bone Conduction, Implanted 1Instrument, Ent Manual Surgical 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240614	Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS	2024-07-10
US	K213733	Ponto 5 SuperPower	2021-12-16
US	K211640	Ponto 5 Mini	2021-08-10
BR	10356029001	Instrumental descartável Ponto	Class II
BR	10356029002	Instrumental Reutilizável Ponto	Class I
BR	10356020106	Instrumental Não Cortante Não Articulado para Implante Coclear	Class I
CA	83677	ABUTMENT (PONTO BONE ANCHORED HEARING SYSTEM)	Class III
CA	83678	COVER SCREW (PONTO BONE ANCHORED HEARING SYSTEM)	Class III
CA	83680	PONTO BONE ANCHORED HEARING SYSTEM - PONTO & PONTO PRO SOUND PROCESSORS	Class II

Oticon Medical AB

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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