Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710516

FEI Number

3001802794

Entity Name

TAKAGI SEIKO CO., LTD.

City/State/Country

NAKANO-SHI Nagano, JP

Establishment Address

330-2 IWAFUNE, NAKANO-SHI Nagano 383-8585, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

TAKAGI SEIKO CO., LTD. (Owner Number: 9025906)

Owner / Operator Contact Address

330-2 IWAFUNE, --, NAKANO-SHI, NAGANO, JP-NOTA 383-8585, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MARCO AT-8 APPLANATION TONOMETER APPLANATION TONOMETER AT-2 MARCO ORION OPHTHALMIC WORKSTATION MOBILE SLIT LAMP MICROSCOPE MS1 MARCO AT-9 APPLANATION TONOMETER APPLANATION TONOMETER AT-1 OM-9 OPERATING MICROSCOPE OM-19 OPERATING MICROSCOPE OM-6 OPERATING MICROSCOPE VIEW TESTER VT-5 CHART PROJECTOR CP-40 MARCO ENCORE MANUAL CHAIR SLIT LAMP MICROSCOPE 30GL MARCO ULTRA M4 MARCO ULTRA M3 SLIT LAMP MICROSCOPE 4ZL MARCO BRAVO CHAIR MARCO TILT CHAIR MARCO ENCORE AUTOMATIC CHAIR Ellex 30XL SLITLAMP MARCO TRIAL LENS FRAME PROJECTION PERIMETER MT 325UD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2018-12-10
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2001-07-26
PUE	Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	Ophthalmic	Class 2	886.1850	2021-11-22
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2017-10-31
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2001-07-25
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2001-07-26
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2001-07-25
HMD	Chair, Ophthalmic, Manual	Ophthalmic	Class 1	886.1140	2001-07-25
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2017-04-16
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	2001-07-25
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2007-01-10
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2001-07-25
HOO	Perimeter, Ac-Powered	Ophthalmic	Class 1	886.1605	2001-07-25

Official Correspondent

TORU HAGIWARA

US Agent Details

Richard Wynkoop Email: rich@vision28.com Phone: (541) 6049654

Related Public Records

Same Entity

TAKAGI SEIKO 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 9710516. Last updated year: 2026. Please use registration number 9710516 when referencing this establishment in official correspondence.