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Otsuka Electronics USA, Inc.

USA · Fort Collins

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States1 registration records, 4 510(k), 0 PMA, 5 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: OTSUKA ELECTRONICS CO., LTD.

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)

Market	Identifier	Name	Class / date
US	K942953	ORACLE MRI WHOLE BODY MR IMAGING SYSTEM	1994-09-30
US	K942776	MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1	1994-09-21
US	K925858	OE 1.5 SI	1993-12-02
CA	37504	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	Class II
CA	83703	DISCRETE CLINICAL CHEMISTRY ANALYZER NS-PLUS	Class II
CA	77027	INFRARED SPECTROPHOTOMETER POCONE	Class II

Otsuka Electronics USA, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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