Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027616027

FEI Number

3027616027

Entity Name

SHANGHAI SUOKANG MEDICAL IMPLANTS CO., LTD.

City/State/Country

Shang hai Shanghai, CN

Establishment Address

Building 2, No. 613, Suide Rd., Putuo Region, Shanghai ,China 200331, Shang hai Shanghai 200331, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Suokang Medical Implants Co., Ltd. (Owner Number: 10088383)

Owner / Operator Contact Address

Building 2, No. 613, Suide Rd., Putuo Region, Shanghai ,China 200331, Shang hai, CN-SH 200331, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201153

PMA Number

N/A

All Registered Proprietary Names

Tisuthes e-PTFE Surgical Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWR	Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery	General, Plastic Surgery	Class 2	878.3300	2023-07-11
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-07-11

Official Correspondent

Xinhua Li

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455889

Related Public Records

Same Entity

Shanghai Suokang Medical Implants 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
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22

Similar Registrations

Registration Number	Establishment Name	Location
3005619880	Boston Scientific Corporation	Roswell, GA, US
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US
8020712	LOCKDOWN MEDICAL LIMITED	Redditch Worcestershire, GB
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
3009514842	NOVUS SCIENTIFIC INC	Wrentham, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027616027. Last updated year: 2026. Please use registration number 3027616027 when referencing this establishment in official correspondence.