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Oticon A/S

Denmark · Smorum
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
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
3active device licences
Class II 3
9 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
5device registrations
CLASS B 5
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 2IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
15active registrations
Class 2a 15
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, 2 510(k), 0 PMA, 5 excluded
Brazil4 confirmed, 3 excluded
Saudi Arabia1 confirmed, 1 excluded
Canada3 confirmed, 2 excluded
Manufacturer names merged into this page: Oticon A/S · OTICON A/S

Company information

Country
Denmark
City
Smorum

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.

FDA 510(k) clearances by year

11995 · K951002
12014 · K133308

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)

MarketIdentifierNameClass / date
USK133308TINNITUS SOUNDSUPPORT2014-03-18
USK951002AMENDMENTS TO MULTIFOCUS1995-09-18
BR10356029004STREAMER PROClass II
BR10356020077APARELHO AMIGO DE AMPLIFICAÇÃO SONORAClass II
BR10356029003STREAMERClass II
SAME0000015324SFDAA00001Streamer Pro XM—
CA99825HEARING AID BATTERIESClass II
CA102684OTICON ONClass II
CA103655OTICON REMOTECARE APPClass II

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