Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008516548

FEI Number

3008516548

Entity Name

NANJING SHUANGWEI BIOTECHNOLOGY CO., LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No.123, Huakang Road, Jiangbei New Area, Nanjing Jiangsu 210000, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Nanjing Shuangwei Biotechnology Co., Ltd. (Owner Number: 10095089)

Owner / Operator Contact Address

No.123, Huakang Road, Jiangbei New Area, Nanjing, CN-JS 210000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-01-23

Official Correspondent

Tingting Zhang

US Agent Details

Andy Smith Business: GRZAN GROUP INC Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

Nanjing Shuangwei Biotechnology 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
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23
K251231	ABBOTT MEDICAL	ViewFlex X ICE Catheter, Sensor Enabled	2025-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

Similar Registrations

Registration Number	Establishment Name	Location
3013844297	DANELIS MEDICAL LIMITED	Rhayader Powys, GB
1058584	Sterigenics US LLC	Charlotte, NC, US
3017894900	Philips Ultrasound LLC	Cambridge, MA, US
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
3019216	Philips Ultrasound LLC	BOTHELL, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008516548. Last updated year: 2026. Please use registration number 3008516548 when referencing this establishment in official correspondence.