Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010796396

FEI Number

3010796396

Entity Name

S.E.S. HEALTHCARE PRODUCTS CO., LTD.

City/State/Country

Suzhou City Anhui, CN

Establishment Address

East of Pingshan Road, South of Qishi Road, Economic Development Zone, Lingbi County, Suzhou City Anhui 234200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

S.E.S. HEALTHCARE PRODUCTS CO., LTD. (Owner Number: 10026098)

Owner / Operator Contact Address

Feng Xia Road, Shuang Feng Development Zone, Heifei, CN-AH 231131, 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
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-06-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-28

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

S.E.S. HEALTHCARE PRODUCTS 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
3044906632	S.E.S. HEALTHCARE PRODUCTS CO., LTD.	Huainan Anhui, CN
3007082897	S.E.S. HEALTHCARE PRODUCTS CO., LTD.	Heifei Anhui, CN
3011494917	S.E.S. HEALTHCARE PRODUCTS CO., LTD.	Huainan City Anhui, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010796396. Last updated year: 2026. Please use registration number 3010796396 when referencing this establishment in official correspondence.