Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031240343

FEI Number

3031240343

Entity Name

SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 100, Tangjiabang Road, Suzhou Industrial Park, Suzhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Hengrui Hongyuan Medical Co., Ltd. (Owner Number: 10090677)

Owner / Operator Contact Address

No. 100, Tangjiabang Road, Suzhou Industrial Park, Suzhou, CN-JS 215123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210562

PMA Number

N/A

All Registered Proprietary Names

RAPIDTHRU DA Micro Catheter and Guidewire System HRSpheres Narrow-Size Embolic Microspheres

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-04-28
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-04-28
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2024-04-28

Official Correspondent

Angela Wang

US Agent Details

DJ Fang Business: PUREVISION AI, INC. Email: us-agent@purefda.com Phone: (201) 5035758

Related Public Records

Same Entity

Suzhou Hengrui Hongyuan 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
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031240343. Last updated year: 2026. Please use registration number 3031240343 when referencing this establishment in official correspondence.