Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013502418

FEI Number

3013502418

Entity Name

CAM A P I MEDICAL CO., LTD.

City/State/Country

Angsnuol District Kandal, KH

Establishment Address

Chhun Hong Ind. Park, National Rd. No. 4, Svaychrom Village, Beckchan Commune, Angsnuol District Kandal 08301, KH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cam A P I Medical Co., Ltd. (Owner Number: 10053178)

Owner / Operator Contact Address

Chhun Hong Ind. Park, National Rd. No. 4, Svaychrom Village, Beckchan Commune, Angsnuol District, KH-8 08301, KH

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
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2018-07-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-02-10
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-05-29
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2018-12-04
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	General, Plastic Surgery	Class 2	878.4040	2025-05-29
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2016-12-09
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-07-06
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-07-23
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2016-12-09
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2025-08-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-07-23

Official Correspondent

Clark Lin

US Agent Details

Solomon Chen Email: solomon@aplusgroup.net Phone: (909) 4387898

Related Public Records

Same Entity

Cam A P I Medical 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
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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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
3042480961	SURGI-SERVE LLC	Bloomington, IN, US
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
3017430544	CARMAFIL	Martinez, GA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
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 3013502418. Last updated year: 2026. Please use registration number 3013502418 when referencing this establishment in official correspondence.