Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009512503

FEI Number

3009512503

Entity Name

MEDSOURCE FACTORY,INC.

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

NO.160 JIN SHENG DONG LU, JINTAN DISTRICT, CHANGZHOU Jiangsu 213200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDSOURCE FACTORY,INC. (Owner Number: 10086559)

Owner / Operator Contact Address

NO.160 JIN SHENG DONG LU, JINTAN DISTRICT, CHANGZHOU, CN-JS 213200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Burn Sheet IV start kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2022-11-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-04-22
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2022-11-19
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2022-11-19
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-01-29
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2025-08-26
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-03-20
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2022-11-19
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2024-05-16
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2022-11-19
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-19
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2025-04-22
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2025-05-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-11-18
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2022-11-19
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2022-11-19

Official Correspondent

LU GUOFANG

US Agent Details

YANG Xiangfang Business: AIKEN CORP Email: info@Aikencorp.com Phone: (909) 8681800

Related Public Records

Same Entity

MEDSOURCE FACTORY,INC.

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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3038279528	3H MEDICAL (THAILAND) CO., LTD.	Nong Yai District Chon Buri, TH
1054786	E.M. ADAMS CO., INC.	FORT PIERCE, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009512503. Last updated year: 2026. Please use registration number 3009512503 when referencing this establishment in official correspondence.