Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015960676

FEI Number

3015960676

Entity Name

ANDERSEN INDUSTRIES CO., LTD.

City/State/Country

Angsnoul District Kandal, KH

Establishment Address

National Road.4, Srah Sangkom (Srassangkom) Village, Peuk, Commune, Angsnoul District Kandal 08315, KH

Establishment Type(s)

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

Owner / Operator

Andersen Industries Co., Ltd. (Owner Number: 10061228)

Owner / Operator Contact Address

National Road.4, Srah Sangkom (Srassangkom) Village, Peuk,Commune, Angsnoul District, KH-8 08315, KH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-08-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-08-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-05-10
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-31
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-09-30
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2020-03-12
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-03-14
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2019-09-25
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-08-11
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-08-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-08-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-07-21
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-08-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-12-11
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2019-09-25
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-08-11
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-01-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-07
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-09-10
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2019-09-25
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	General, Plastic Surgery	Class 2	878.4040	2023-12-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-04-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-08-11
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-10
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-09-25

Official Correspondent

Clark Lin

US Agent Details

Solomon Chen Email: solomon@aplusgroup.net Phone: (909) 5915168

Related Public Records

Same Entity

Andersen Industries 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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24

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.

Similar Registrations

Registration Number	Establishment Name	Location
3030954512	MMI NORTH AMERICA, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015960676. Last updated year: 2026. Please use registration number 3015960676 when referencing this establishment in official correspondence.