Wsaud A/S

Denmark · Lynge

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

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

3valid device licences

Class I 3

SGSingaporeHSA SMDR

40device registrations

CLASS B 40

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 5IIa 6

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

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 States0 registration records, 2 510(k), 0 PMA

Brazil16 confirmed, 0 excluded

Manufacturer names merged into this page: WSAUD A/S

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233464	WSA Self-Fitting Hearing Aid Gen 2	2024-02-09
US	K220403	Vibe SF Self-Fitting Hearing Aid	2022-08-12
BR	80872830001	APARELHO AUDITIVO INTRA DIGITAL AUDIO SERVICE	Class II
BR	80872830002	APARELHO AUDITIVO RETRO DIGITAL AUDIO SERVICE	Class II
BR	80872839005	Aparelhos de Audição Intra Digital Audibel	Class II

Wsaud A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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