Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018501318

FEI Number

3018501318

Entity Name

CREWT MEDICAL SYSTEMS, INC

City/State/Country

Shinjuku-ku Tokyo, JP

Establishment Address

3F, TH1 Bldg, 3-11, Tsukudo-machi, Shinjuku-ku Tokyo 162-0821, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CREWT Medical Systems, INC (Owner Number: 10081331)

Owner / Operator Contact Address

3F, TH1 Bldg, 3-11, Tsukudo-machi, Shinjuku-ku, JP-13 162-0821, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMOvifa IMOvifa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2022-12-15
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2021-04-05

Official Correspondent

Tetsuya Eguchi

US Agent Details

Michael Nilo Business: Nilo Medical Consulting Group Email: michael.nilo@nilomed.com Phone: (717) 4214396

Related Public Records

Same Entity

CREWT Medical Systems, 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 3018501318. Last updated year: 2026. Please use registration number 3018501318 when referencing this establishment in official correspondence.