Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030344

FEI Number

3002808077

Entity Name

SAGAMI RUBBER INDUSTRIES CO., LTD.

City/State/Country

ATSUGI-SHI Kanagawa, JP

Establishment Address

2-1, MOTO-CHO, ATSUGI-SHI Kanagawa 243-0002, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SAGAMI RUBBER INDUSTRIES CO., LTD. (Owner Number: 9001731)

Owner / Operator Contact Address

2-1 MOTO-CHO, ATSUGI-SHI, KANAGAWA-KEN, JP-NOTA 243-0002, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K946376

PMA Number

N/A

All Registered Proprietary Names

Kimono MicroThin with Aqua Lube Reality Ultra Lubricated Kimono Kimono Kimono

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2012-10-31
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-02-29
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-02-29
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-02-29

Official Correspondent

No official correspondent registered.

US Agent Details

David Mayer Business: Mayer Laboratories Email: davidm@mayerlabs.com Phone: (510) 2295300

Related Public Records

Same Entity

SAGAMI RUBBER INDUSTRIES CO., LTD.

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 8030344. Last updated year: 2026. Please use registration number 8030344 when referencing this establishment in official correspondence.