Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007082897

FEI Number

3007082897

Entity Name

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

City/State/Country

Heifei Anhui, CN

Establishment Address

Feng Xia Road, Jinzang Road, Shuang Feng Development Zone, Heifei Anhui 231131, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),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

Medline General Surgery Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2018-11-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-06-09
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-03-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-01
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-23
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2011-09-07
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2014-02-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-04-12

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
3011494917	S.E.S. HEALTHCARE PRODUCTS CO., LTD.	Huainan City Anhui, CN
3010796396	S.E.S. HEALTHCARE PRODUCTS CO., LTD.	Suzhou City Anhui, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007082897. Last updated year: 2026. Please use registration number 3007082897 when referencing this establishment in official correspondence.