Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038161965

FEI Number

3038161965

Entity Name

Ophtecs Manufacturing Ltd.

City/State/Country

Toyooka Hyogo, JP

Establishment Address

26 Kamiyoshidai, Toyooka Hyogo 668-0831, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ophtecs Manufacturing Ltd. (Owner Number: 10094487)

Owner / Operator Contact Address

26 Kamiyoshidai, Toyooka, JP-28 668-0831, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251876

PMA Number

N/A

All Registered Proprietary Names

cleadew GP hydra one

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2025-12-03

Official Correspondent

Haruki Nakagawa

US Agent Details

Bret Andre Business: EYEREG CONSULTING INC. Email: bandre@fdapproval.com Phone: (503) 3725226

Related Public Records

Same Entity

Ophtecs Manufacturing Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038161965. Last updated year: 2026. Please use registration number 3038161965 when referencing this establishment in official correspondence.