Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018240684

FEI Number

3018240684

Entity Name

YASUI CO., LTD.

City/State/Country

Higashiusuki-gun Miyazaki, JP

Establishment Address

2725 Oazakakusa, Kadogawa-cho, Higashiusuki-gun Miyazaki 889-0697, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yasui Co., Ltd. (Owner Number: 10085409)

Owner / Operator Contact Address

2725 Oazakakusa, Kadogawa-cho, Higashiusuki-gun, JP-45 889-0697, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KA-1 Koplight autoclavable sheath KS-5S Koplight S blade KS-6HS Koplight HT S blade KS-5HS Koplight HT S blade KG-2-SET Koplight light handle set (infrared cut-off model) KS-4S Koplight S blade KG-2 Koplight light handle (Infrared cut-off model) KG-1 Koplight light handle KS-1S Koplight S blade KS-2S Koplight S blade KY-1 Koplight light handle finger hook KS-4HS Koplight HT S blade KP-1 Koplight light handle O-ring KS-3S Koplight S blade KD-1 Koplight battery inserter KG-1-SET Koplight light handle set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2023-12-10

Official Correspondent

Koji Miyata

US Agent Details

Takahiro Haruyama Business: GLOBIZZ CORPORATION Email: register@globizz.net Phone: (310) 5383833

Related Public Records

Same Entity

Yasui Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018240684. Last updated year: 2026. Please use registration number 3018240684 when referencing this establishment in official correspondence.