Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011347300

FEI Number

3011347300

Entity Name

LEO MEDICAL CO., LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Changzhou Jiangsu 213022, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Leo Medical Co., Ltd. (Owner Number: 10092699)

Owner / Operator Contact Address

No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Changzhou, CN-JS 213022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172985

PMA Number

N/A

All Registered Proprietary Names

LUMIFLEXTM 3-Stage Balloon Dilatation Catheter KZ0880H1 KZ1030E1 KZ1230H3 KZ0855G1 KZ1280F0 KZ0680H0 BX00715512W KZ1080F0 KZ1855H1 KZ1580H1 KZ1530E0 KZ1530H3 KZ1030H0 KZ1080F3 KZ1880F0 KZ0680F3 BX00715508W KZ0830H0 KZ1030H3 BX00718018W KZ1255G1 BX00718012W KZ0630E0 KZ0680F1 KZ1055G3 BX00718008W BX00715518W KZ1230H1 KZ0630E1 KZ0655H0 KZ1080H1 BX00715510 KZ1255H1 BX00715506 KZ1555H3 KZ1880F1 KZ1880H1 KZ0830E1 KZ1030H1 KZ1555H1 KZ0830E0 KZ1055G1 KZ1530H0 KZ1230E3 KZ1055G0 BX00718015W KZ1055H1 KZ1230E1 KZ0680H3 KZ1580F0 KZ0655G3 KZ0655G0 KZ0880F1 KZ1855G3 KZ1080H3 KZ0680F0 KZ1530H1 KZ0830H3 KZ1555H0 KZ1280F1 KZ1880H3 KZ0630H1 KZ0855H3 KZ0830E3 KZ1555G0 KZ1555G1 BX00718006W KZ0855H0 KZ1855G1 KZ0680H1 KZ0655H3 KZ1255G3 KZ1255H3 KZ0880F3 KZ0830H1 KZ1230H0 BX00715506W BX00715510W KZ0880H0 KZ0655G1 KZ1855H0 KZ0655H1 KZ1280F3 KZ1055H0 BX00715512 KZ1855H3 KZ1530E3 KZ1080H0 KZ0880F0 KZ1580F1 KZ1080F1 KZ1280H3 KZ1580H0 KZ0855H1 KZ0630H0 KZ1030E3 BX00715515W KZ1280H1 KZ0630H3 BX00715518 KZ1530E1 Single-use Balloon Dilatation Catheter KZ0855G0 BX00718010W KZ1230E0 KZ1855G0 KZ1880H0 KZ1030E0 KZ0880H3 KZ0630E3 KZ1255H0 KZ1580F3 BX00715515 KZ1255G0 KZ1580H3 BX00715508 KZ1055H3 KZ0855G3 KZ1555G3 KZ1880F3 KZ1280H0 Loop40B0-LD165D0 Loop20B0-LD195D0 Loop30B0-LD165D0 EN10701 Loop40B0-LD195D0 Loop15B0-LD230D0 Loop15B0-LD165D0 Loop30B0-LD230D0 Loop40B0-LD230D0 Loop20B0-LD165D0 Loop30B0-LD195D0 Loop20B0-LD230D0 Loop15B0-LD195D0 Ligation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-02-06
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2025-02-06
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2025-02-06
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2025-02-06

Official Correspondent

Guojun Zhang

US Agent Details

Anny Zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Leo Medical 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
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K000397	Boston Scientific Corp	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	2000-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011347300. Last updated year: 2026. Please use registration number 3011347300 when referencing this establishment in official correspondence.