SHENZHEN ANTMED CO. LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3007048453

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007048453
FEI Number
3007048453
Entity Name
SHENZHEN ANTMED CO. LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
No.3 Hualian Ave., Songshanhu District, Dongguan Guangdong 523800, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen Antmed Co. Ltd (Owner Number: 10025888)
Owner / Operator Contact Address
18 Jinhui Ave., Pingshan New District, Shenzhen, CN-GD 518122, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K131770
PMA Number
N/A

All Registered Proprietary Names

Disposable Pressure Transducer ANT Angiographic Syringes ANT Inflation Device and ANT Inflation Device Compact Pack Pressure Connecting Tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2009-08-19
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2008-05-18
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2011-10-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2014-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Shenzhen Antmed 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
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
Z-0002-2017 Merit Medical Systems, Inc. 2
Merit Inflation Syringe Kit. Catalog Number KOS-02857

Similar Registrations

Registration Number Establishment Name Location
1423395 MEDLINE INDUSTRIES, LP - SPT Waukegan, IL, US
3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN
1422634 MEDLINE INDUSTRIES, LP (Northpoint Services) Waukegan, IL, US
1713468 ICU MEDICAL, INC Salt Lake City, UT, US
1721676 Sterigenics U.S., LLC Salt Lake City, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007048453. Last updated year: 2026. Please use registration number 3007048453 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.