Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011564431

FEI Number

3011564431

Entity Name

Beijing Target Medical Technologies Inc.

City/State/Country

Beijing, CN

Establishment Address

No.60, Shunren Rd., Shunyi District, Beijing 101300, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

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

Shoocin Introducer Kit Guidewire Introducer Guidewire Torquer Brilliant Introducer Kits Hoper Inflation Device Y-Hemostasis Valve Vasc Band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-11
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2018-05-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-06-07
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-12-11
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-05-03
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2018-05-11
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2014-11-18

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
3018312328	LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Beijing, CN
3008002401	LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD	Beijing, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011564431. Last updated year: 2026. Please use registration number 3011564431 when referencing this establishment in official correspondence.