Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612392

FEI Number

1000255210

Entity Name

SEIKAGAKU CORPORATION, TAKAHAGI PLANT

City/State/Country

TAKAHAGI-SHI Ibaraki, JP

Establishment Address

258-5, AZA-MATSUKUBO, OAZA-AKAHAMA, TAKAHAGI-SHI Ibaraki 318-0001, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SEIKAGAKU CORPORATION (Owner Number: 9043759)

Owner / Operator Contact Address

6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo, JP-NOTA 100-0005, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080020

All Registered Proprietary Names

Gel-One

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2011-09-12

Official Correspondent

Hiroshi Murase

US Agent Details

Thomas Bardo Business: NELSON MULLINS RILEY & SCARBOROUGH LLP Email: Tom.Bardo@nelsonmullins.com Phone: (202) 6892817

Related Public Records

Same Entity

SEIKAGAKU CORPORATION

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 9612392. Last updated year: 2026. Please use registration number 9612392 when referencing this establishment in official correspondence.