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Home›USA›Rion Co. Ltd. Dba Rion Acoustic Device

Rion Co. Ltd. Dba Rion Acoustic Device

USA · Bristol
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Singapore, South Korea, Israel — 5 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
53510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 53 510(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
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 3Class II 2
SGSingaporeHSA SMDR
6device registrations
CLASS B 6
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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, 53 510(k), 0 PMA

Company information

Country
USA
City
Bristol

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

111979
91980
51981
61982
61983
51984
61985
21986
11988
11992
11993

Registration details (sample)

MarketIdentifierNameClass / date
USK931320RIONET HEARING AID HB-53W1993-05-05
USK915319RIONET HEARING AID HB-52AS1992-01-09
USK874510RIONET HEARING AID HB-751988-02-23

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