Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011676762

FEI Number

3011676762

Entity Name

Tae-Chang Industrial Co., Ltd.

City/State/Country

Gumi-si Gyeongbuk, KR

Establishment Address

127, Sanho-daero, Gumi-si Gyeongbuk 39378, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tae-Chang Industrial Co., Ltd. (Owner Number: 9062236)

Owner / Operator Contact Address

8-18, Bojeokdong-gil, Useong-myeon, Gongju-si, KR-44 32533, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180720

PMA Number

N/A

All Registered Proprietary Names

Exel Spinal Needles True plus True plus Quinta tip Medifine Pen Needle 3 Bevel Insuflo Medifine Pen Needle Quinta 5 Bevel Trividia health Insuflo Quinta TRUEplus 3 bevel Sterile pen needles TRUEplus 5 bevel Sterile pen needles CVS TRUEplus 50CT 5 bevel Sterile pen needles WGN TRUEplus 50CT 5 bevel Sterile pen needles TRUEplus 50CT 5 bevel Sterile pen needles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-02-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-02-27

Official Correspondent

Jung-ryun In

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

Tae-Chang Industrial Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004504731	Tae-Chang Industrial Co., Ltd.	Gongju-si Chungnam, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US
3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011676762. Last updated year: 2026. Please use registration number 3011676762 when referencing this establishment in official correspondence.