Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006122980

FEI Number

3006122980

Entity Name

OKAMOTO INDUSTRIES, INC.

City/State/Country

RYUGASAKI-SHI, IBARAKI-PREF, JP

Establishment Address

NO.1, NISHIYAMA-ITABASHI-CHO,, RYUGASAKI-SHI, IBARAKI-PREF 301-0801, JP

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OKAMOTO INDUSTRIES, INC. (Owner Number: 8031642)

Owner / Operator Contact Address

27-12, 3-CHOME HONGO,, BUNKYO-KU, TOKYO, JP-NOTA 113-8710, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090259

PMA Number

N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2013-09-24
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2022-09-08
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2021-02-10
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

Hisayuki Naito Business: Okamoto U.S.A., Inc. Email: okamotousa@okamotousa.com Phone: (203) 3780003

Related Public Records

Same Entity

OKAMOTO INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006122980. Last updated year: 2026. Please use registration number 3006122980 when referencing this establishment in official correspondence.