Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614709

FEI Number

3009384766

Entity Name

DR. JAPAN CO., LTD.

City/State/Country

Gyoda City Saitama, JP

Establishment Address

4-15-1 Nagano, Gyoda City Saitama 361-0023, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DR. JAPAN CO., LTD. (Owner Number: 9036222)

Owner / Operator Contact Address

4-15-1 Nagano, Gyoda-City, JP-11 361-0023, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RELI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2017-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

SANJIV KUMAR Business: MYCO MEDICAL SUPPLIES, INC. Email: QA@mycomedical.com Phone: (919) 4602535

Related Public Records

Same Entity

DR. JAPAN 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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
3029952419	DIAMINY MEDICAL AESTHETICS	Shanghai, CN
3020664622	Pneumeric, Inc.	Luverne, MN, US
3005748921	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN
9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614709. Last updated year: 2026. Please use registration number 9614709 when referencing this establishment in official correspondence.