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Home›Japan›OTSUKA ELECTRONICS CO., LTD.

OTSUKA ELECTRONICS CO., LTD.

Japan · Hirakata
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Russia — 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
3listed device types
Class I 1Class II 2Class III 0
plus 1 registration records and 4 510(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
3active device licences
Class II 3
5 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States1 registration records, 4 510(k), 0 PMA, 5 excluded
Canada3 confirmed, 1 excluded
Manufacturer names merged into this page: OTSUKA ELECTRONICS CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Otsuka Electronics USA, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Hirakata

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

11992 · K920543
11993 · K925858
21994 · K942953

FDA listed device types

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) 1Calibrator, Secondary 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK942953ORACLE MRI WHOLE BODY MR IMAGING SYSTEM1994-09-30
USK942776MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S11994-09-21
USK925858OE 1.5 SI1993-12-02
CA37504UBIT-IR300 INFRARED SPECTROMETRY SYSTEMClass II
CA83703DISCRETE CLINICAL CHEMISTRY ANALYZER NS-PLUSClass II
CA77027INFRARED SPECTROPHOTOMETER POCONEClass II

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