Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006942602

FEI Number

3006942602

Entity Name

HAOLANG TECHNOLOGY (FOSHAN) LIMITED CORPORATION

City/State/Country

Foshan Guangdong, CN

Establishment Address

Xinyuan 2nd RD, Jili Industrial Park, Nanzhuang, ChanCheng District, Foshan Guangdong 528061, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Haolang Technology (Foshan) Limited Corporation (Owner Number: 10067742)

Owner / Operator Contact Address

Xinyuan 2nd RD, Jili Industrial Park, Nanzhuang, ChanCheng District, Foshan, CN-GD 528061, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arterial Catheter CT CVC Umbilical Vessels Catheter Midline Catheter Peripherally Inserted Central Catheter Hemodialysis Catheter NEEDLE-LESS VALVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-04-06
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2021-05-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-04-06
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2020-04-06
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-06-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-04-06

Official Correspondent

Yongpeng Feng

US Agent Details

Lisa Xu Business: Haolang Medical USA Corporation Email: lisa.xu@haolangmed.com Phone: (425) 5036325

Related Public Records

Same Entity

Haolang Technology (Foshan) Limited Corporation

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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006942602. Last updated year: 2026. Please use registration number 3006942602 when referencing this establishment in official correspondence.