Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009132348

FEI Number

3009132348

Entity Name

REXXAM.CO., LTD.

City/State/Country

Takamatsu Kagawa, JP

Establishment Address

958 Ikeuchi, Konan-cho, Takamatsu Kagawa 761-1494, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Rexxam.Co., Ltd. (Owner Number: 10034243)

Owner / Operator Contact Address

958 Ikeuchi, Konan-cho, Takamatsu, JP-37 761-1494, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OptoChek Plus RET-700 ACCUREF R800 ACCUREF K900 WAM-5500 N Vision-K5001 LCD-1000 LCD-1000P CP-500 PDM DIGITAL PD METER PD-82II SightChek DR-900 TL-34P TL-35M

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2010-11-17
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2017-09-18
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2017-10-13
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2017-10-13
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2010-11-17
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2018-09-20

Official Correspondent

Yoshihiro Kikuchi

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Rexxam.Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K900478	Woodlyn, Inc.	WOODLYN FULL APERTURE TRIAL LENS SET	1990-02-21

Similar Registrations

Registration Number	Establishment Name	Location
3023983572	PLENOPTIKA EUROPE SLU	Madrid Madrid (Province), ES
3008058416	View-M TECHNOLOGY CO., LTD	Gunpo-si Gyeonggi, KR
3013575858	APPASAMY ASSOCIATES PRIVATE LIMITED ( THIRUBHUVANAI))	Mannadipet Commune Puducherry, IN
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3045062165	NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO., LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009132348. Last updated year: 2026. Please use registration number 3009132348 when referencing this establishment in official correspondence.