HomeDenmarkWIDEX A/S

WIDEX A/S

Denmark
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in Brazil, Singapore, South Korea, Australia, Israel, Russia — 6 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
7registered devices
Class II 7
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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
19device registrations
CLASS B 19
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
10active registrations
Class 2a 10
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, 0 510(k), 0 PMA, 2 excluded
Brazil7 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: WIDEX A/S

Company information

Country
Denmark

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
BR80872830013APARELHOS AUDITIVOS RETROAURICULARES SÉRIE MENU.Class II
BR80872830016WIDEX UNIQUE BTE.Class II
BR80872830019APARELHO AUDITIVO DIGITAL RETROAURICULARClass II

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