HomeGermanyAUDIFON - GMBH & CO.KG

AUDIFON - GMBH & CO.KG

Germany · Kolleda
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, 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
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
2 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States2 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: AUDIFON - GMBH & CO.KG · AUDIFON GMBH & CO. KG · AUDIFON GMBH & CO

Company information

Country
Germany
City
Kolleda

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

12009 · K091552

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK091552SWITCH TRT2009-08-12
BR80220270037APARELHOS AUDITIVOS AUDIX RETROAURICULARClass II

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