HomeDenmarkSBO HEARING A/S

SBO HEARING A/S

Denmark · Smorum
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in Brazil, Canada, Taiwan, 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class II 31
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
9 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
40device registrations
CLASS B 40
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 2IIa 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 6
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.

Brazil31 confirmed, 0 excluded
Manufacturer names merged into this page: SBO HEARING 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.

Registration details (sample)

MarketIdentifierNameClass / date
BR10356029015Aparelho auditivo retroauricular rubyClass II
BR10356029021Aparelho auditivo retroauricular OTICON MOREClass II
BR10356029049Família de aparelhos auditivos intraauriculares plataforma KenobiClass II

Similar companies

Axelgaard Manufacturing Co., Ltd.
Denmark · markets 8
BrainCapture ApS
Denmark · markets 3
Brüsch Medical Aps
Denmark · markets 0
Carmo A/S
Denmark · markets 0
Covi Precision A/S
Denmark · markets 0
CTS Corporation
Denmark · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →