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Auditdata A/S

Denmark · Copenhagen
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
5active device licences
Class II 5
10 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 1IIa 6
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States4 registration records, 1 510(k), 0 PMA, 1 excluded
Canada5 confirmed, 1 excluded
Manufacturer names merged into this page: Auditdata A/S · AUDITDATA A/S

Company information

Country
Denmark
City
Copenhagen

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

12012 · K113831

FDA listed device types

Otoscope 1Cushion, Earphone (For Audiometric Testing) 1Calibrator, Hearing Aid / Earphone And Analysis Systems 1Audiometer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK113831PRIMUS HEARING INSTRUMENT TEST UNIT2012-04-19
CA73895AMPLITUDE T-SERIES AUDIOMETERSClass II
CA91385OTOPROClass II
CA92187OTOSPHEREClass II

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