Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018312328

FEI Number

3018312328

Entity Name

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

City/State/Country

Beijing, CN

Establishment Address

Building 5 No. 21 Courtyard, Panlong West Road, Pinggu District, Beijing 101204, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lepu Medical Technology (Beijing) Co., Ltd (Owner Number: 10038811)

Owner / Operator Contact Address

No.37 Chaoqian Rd.,, Changping District, Beijing, CN-BJ 102200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vasc Band Guidewire Introducer Guidewire Torquer Y-Hemostasis Valve Inflation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2014-11-18
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2018-05-11
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2018-05-11
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-05-03

Official Correspondent

Ling Ge

US Agent Details

Xu Wen Email: info@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Lepu Medical Technology (Beijing) Co., Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011564431	Beijing Target Medical Technologies Inc.	Beijing, CN
3008002401	LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Beijing, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018312328. Last updated year: 2026. Please use registration number 3018312328 when referencing this establishment in official correspondence.