Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013548473

FEI Number

3013548473

Entity Name

SESMED (CAMBODIA) HEALTHCARE PRODUCT CO. LTD.

City/State/Country

Sihanoukville Preah Sihanouk, KH

Establishment Address

SSEZ C31-03 No. 4 National Road 212km, Prey Nob District, Sihanoukville Preah Sihanouk 18000, KH

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SESMED (Cambodia) Healthcare Product Co. Ltd. (Owner Number: 10054380)

Owner / Operator Contact Address

Feng Xia Road Shuangfeng Development Zone, Hefei, CN-AH 231131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gown,sleeve Gown, Surgical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-05-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-01
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-03-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-11-01

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

SESMED (Cambodia) Healthcare Product 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013548473. Last updated year: 2026. Please use registration number 3013548473 when referencing this establishment in official correspondence.