Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026383899

FEI Number

3026383899

Entity Name

Innomed Healthcare Products (Cambodia) Co., Ltd.

City/State/Country

Sihanoukville Preah Sihanouk, KH

Establishment Address

Kilometer No.175, National Road No.4, Sihanoukville Preah Sihanouk 180104, KH

Establishment Type(s)

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

Owner / Operator

Innomed Healthcare Products (Cambodia) Co., Ltd. (Owner Number: 10087327)

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

Medline Surgical Gown Medline Surgical Drape Medline Surgical Gown

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	2023-02-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-02-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-02-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-13
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-13

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

Innomed Healthcare Products (Cambodia) 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026383899. Last updated year: 2026. Please use registration number 3026383899 when referencing this establishment in official correspondence.