Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019012929

FEI Number

3019012929

Entity Name

ACE MEDICAL INDUSTRy CO., LTD.

City/State/Country

Yangju-si Gyeonggi, KR

Establishment Address

57-14 , Gwangjeok ro 228beon gil, Gwang jeok myeon, Yangju-si Gyeonggi 11414, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ace Medical Industry Co., Ltd. (Owner Number: 10081789)

Owner / Operator Contact Address

57-14 , Gwangjeok ro 228beon gil, Gwang jeok myeon, Yangju-si, KR-41 11414, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACE Cannula DermaFlex Aspiration Needle Cannulall Q Micro Cannula Eclipse DermaFlex MicroCannula Duo Cannula Q Micro Cannula ACE Cannula Cannulall ACE MESO THERAPIE

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	2021-05-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-05-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-02-06
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2025-05-27

Official Correspondent

Won Bae Joe

US Agent Details

Peter Chung Email: peterchung210@gmail.com Phone: (412) 5128802

Related Public Records

Same Entity

Ace Medical Industry 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

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.
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
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 3019012929. Last updated year: 2026. Please use registration number 3019012929 when referencing this establishment in official correspondence.