Megasoft (China) Co., Ltd.
Registered establishment in Shishi, Fujian, China. 8 device types, 1 clearance.
Megasoft (China) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Respirator, Surgical, Pad, Menstrual, Unscented and 6 other device types. Its earliest product listing with the FDA dates from 2020.
8device types registered with the FDA
1510(k) clearance
Registration
| Registered name | MEGASOFT (CHINA) CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017237783 |
| FEI number | 3017237783 |
| Establishment type | Manufacturer |
Location
| City | Shishi |
|---|---|
| Province | Fujian |
| Address | No.1 Xinqiang Road,Machinery Printing Base,Gaoxin District, |
| Postal code | 362700 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Daily Face Mask• Disposable Face Mask- Disposable Face Mask FOR Kids; Face Mask; Medical Face Mask | 2020 | 439 |
| Bedding, Disposable, Medical | Class 1 | BSY; Nursing Pad; Underpad | 2021 | 308 |
| Catheters, Suction, Tracheobronchial | Class 1 | Table Paper | 2022 | 93 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Chikool Face Mask; Daily Mask; Face Mask | 2020 | 182 |
| Garment, Protective, For Incontinence | Class 1 | Disposable Adult Diaper; Disposable Adult Pants; Disposable Baby Diaper, Dispasable Baby Pants, Incontinence Pads | 2020 | 181 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class 1 | under pad | 2020 | 48 |
| Pad, Menstrual, Unscented | Class 1 | Cooling Pad; Disposable Pad, Disposable Underwear, Sanitary Napkin; Sisters Chikool | 2021 | 132 |
| Respirator, Surgical | Class 2 | KN95; MG KN 95 | 2020 | 118 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213617 | 2022-02-11 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 4000 |
| Main products | Baby care products, Adult incontinence, Feminine hygiene, Wipes, Masks |
| Export markets | 80+ countries |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.