Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017237783

FEI Number

3017237783

Entity Name

MEGASOFT (CHINA) CO.,LTD.

City/State/Country

Shishi Fujian, CN

Establishment Address

No.1 Xinqiang Road,Machinery Printing Base,Gaoxin District,, Hongshan Town,, Shishi Fujian 362700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEGASOFT (CHINA) CO.,LTD. (Owner Number: 10071386)

Owner / Operator Contact Address

No.1 Xinqiang Road,Machinery Printing Base,Gaoxin District,, Hongshan Town,, Shishi, CN-FJ 362700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BSY; Nursing Pad; Underpad Cooling Pad; Disposable Pad, Disposable Underwear, Sanitary Napkin; Sisters Chikool under pad Table Paper KN95; MG KN 95

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-11-03
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-07-08
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2020-05-03
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-06-13
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-21

Official Correspondent

Hanhe Chen

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

MEGASOFT (CHINA) 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017237783. Last updated year: 2026. Please use registration number 3017237783 when referencing this establishment in official correspondence.