Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004617181

FEI Number

3004617181

Entity Name

Nantong Michael Irradiation CO., LTD.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

No.99 Chenggang Road, Gangzha Developing Zone, Nantong Jiangsu 226003, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Nantong Michael Irradiation CO., LTD. (Owner Number: 10038758)

Owner / Operator Contact Address

No.99 Chenggang Road, Gangzha Developing Zone, Nantong, CN-JS 226003, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accessory, Surgical Apparel Gauze/Sponge, Internal X-Ray Detectable Fiber, Medical, Absorbent

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	2014-10-16
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2014-10-16
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2014-10-17

Official Correspondent

Anna Feng

US Agent Details

Anna Feng Email: stayintouch@gmail.com Phone: (630) 7155815

Related Public Records

Same Entity

Nantong Michael Irradiation 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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
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 3004617181. Last updated year: 2026. Please use registration number 3004617181 when referencing this establishment in official correspondence.