Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042190142

FEI Number

3042190142

Entity Name

ANTMED MALAYSIA SDN BHD

City/State/Country

Port Dickson Negeri Sembilan, MY

Establishment Address

Antmed Industrial Park, Lot 8322, Persiaran Springhill, 71010 Port Dickson, Negeri Sembilan, Malaysia., Port Dickson Negeri Sembilan 71010, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Antmed Malaysia SDN BHD (Owner Number: 10094316)

Owner / Operator Contact Address

Antmed Industrial Park, Lot 8322, Persiaran Springhill, 71010 Port Dickson, Negeri Sembilan, Malaysia., Port Dickson, MY-05 71010, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Angiographic Syringes Pressure Connecting Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-11-23
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-11-23

Official Correspondent

Francis Liu

US Agent Details

Molly Chen Email: molly@antmedcorp.com Phone: (240) 4311804

Related Public Records

Same Entity

Antmed Malaysia SDN BHD

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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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3015309643	Merit Medical UK Limited	Earley Reading, GB
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 3042190142. Last updated year: 2026. Please use registration number 3042190142 when referencing this establishment in official correspondence.