Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016927399

FEI Number

3016927399

Entity Name

Omura Kogyo Co., Ltd. Hara Factory

City/State/Country

Numazu Shizuoka, JP

Establishment Address

26-1 Hara, Numazu Shizuoka 410-0312, JP

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

REPROLIFE Inc. (Owner Number: 10073837)

Owner / Operator Contact Address

2-5-3-9F Shinjuku, Shinjuku-ku, JP-13 160-0022, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162051

PMA Number

N/A

All Registered Proprietary Names

Tissue Storage: 10 Cryotec

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2020-05-19

Official Correspondent

Shin Tanaka

US Agent Details

Takahiro Haruyama Business: Globizz Corporation Email: register@globizz.net Phone: (310) 5383860

Related Public Records

Same Entity

REPROLIFE Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013019894	REPROLIFE INC.	Shinjuku-ku Tokyo, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016927399. Last updated year: 2026. Please use registration number 3016927399 when referencing this establishment in official correspondence.