Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005126704

FEI Number

3005126704

Entity Name

ACE MEDICAL

City/State/Country

GOYANG-SI Gyeonggi, KR

Establishment Address

33, NAEYOO-ROAD 124, DEOGYANG-GU, GOYANG-SI Gyeonggi 10264, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACE MEDICAL (Owner Number: 9072378)

Owner / Operator Contact Address

AceMedical Tower, 30, Godeokbizvalley-ro 4-gil, Gangdong-gu, KR-11 05203, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Autofuser Autofuser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2007-12-15
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2011-03-08

Official Correspondent

NAUN KWON

US Agent Details

Divya Raman Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

ACE MEDICAL

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005126704. Last updated year: 2026. Please use registration number 3005126704 when referencing this establishment in official correspondence.