HomeJapanOKAMOTO INDUSTRIES, INC.

OKAMOTO INDUSTRIES, INC.

Japan · Ibaraki-Pref
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Russia — 7 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 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 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
3active device licences
Class II 3
5 including historic records
TWTaiwanTFDA
5valid device licences
Class I 1Class II 4
SGSingaporeHSA SMDR
18device registrations
CLASS B 1CLASS C 17
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 2Class 2b 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 States6 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Canada3 confirmed, 2 excluded
Manufacturer names merged into this page: OKAMOTO INDUSTRIES, INC. · OKAMOTO INDUSTRIES INC. · OKAMOTO INDUSTRIES

Company information

Country
Japan
City
Ibaraki-Pref

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.

Business registration

Legal name
OKAMOTO INDUSTRIES,INC.
Corporate Number
5010001000002
Registration status
Active
Registered capital
JPY 13,047,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Condom, Synthetic 1Condom 1Pack, Hot Or Cold, Disposable 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80189900002ALMOFADA TÉRMICA ADESIVA BODI HEATClass I
CA68879NATURAL RUBBER LATEX CONDOMClass II
CA68880NATURAL RUBBER LATEX CONDOM WITH SPERMICIDAL LUBRICANTClass II
CA89972LATEX CONDOMSClass II

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