Ming FAI Enterprise International Co., Ltd.
Registered establishment in Kowloon, Hong Kong, China. 18 device types.
Ming FAI Enterprise International Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Floss, Dental, Container, I.V. and 16 other device types. Its earliest product listing with the FDA dates from 1998.
Registration
| Registered name | MING FAI ENTERPRISE INTERNATIONAL CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007143236 |
| FEI number | 3007143236 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 明輝實業國際有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Kowloon |
|---|---|
| Province | Hong Kong |
| Address | Unit D3, 8/F, TML Tower, No 3 Hoi Shing Rd |
| Postal code | – |
| Country | China |
Group
Ming FAI Enterprise International Co., Ltd. is one of 2 plants registered under Ming Fai Enterprise International Co., Ltd..
| Plant | City | Device types |
|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | 17 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swab | 2007 | 186 |
| Bedding, Disposable, Medical | Class 1 | O.R. Table Sheets | 2010 | 308 |
| Container, I.V. | Class 2 | Bag Decanter, Bottle Decanter, Vial Decanter | 2013 | 7 |
| Drape, Surgical, Antimicrobial | Class 2 | Drape Surgical, Uro-Catcher | 2013 | 39 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | 3-Ply Disposable Face Mask | 2020 | 182 |
| Fiber, Medical, Absorbent | Class 1 | Cotton ball / Cotton pad | 2007 | 172 |
| Floss, Dental | Class 1 | Dental Floss | 2007 | 151 |
| Media, Coupling, Ultrasound | Class 2 | Sterile Gel | 2018 | 8 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | Class 1 | Knob Covers | 2017 | 12 |
| Operating Room Accessories Table Tray | Class 1 | O.R. Table Sheets | 2010 | 25 |
| Personal Protection Kit | Class 1 | 2020 | 8 | |
| Protector, Skin Pressure | Class 1 | Gel Positioners | 2010 | 101 |
| Set, I.V. Fluid Transfer | Class 2 | Transfer Device | 2013 | 8 |
| Stretcher, Patient Restraint | Class 1 | Safety Straps | 2010 | 20 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Class 2 | Equipment Covers (drape /set-up cover) | 2013 | 9 |
| Tape And Bandage, Adhesive | Class 1 | Adhesive Bandage | 2007 | 353 |
| Toothbrush, Manual | Class 1 | Toothbrush | 1998 | 244 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Probe Covers | 2013 | 44 |
Clearances
No clearance names Ming FAI Enterprise International Co., Ltd. as applicant. 9 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K163050 | 2017-10-25 | MUI | Traditional | Advance Medical Designs, Inc. |
| K011265 | 2001-10-30 | ITX | Traditional | Advance Medical Designs, Inc. |
| K012168 | 2001-09-18 | KKX | Traditional | Advance Medical Designs, Inc. |
| K003670 | 2001-01-26 | KKX | Traditional | Advance Medical Designs, Inc. |
| K852893 | 1985-09-20 | KPE | Traditional | Advance Medical Designs, Inc. |
| K853188 | 1985-08-21 | LHI | Traditional | Advance Medical Designs, Inc. |
| K852777 | 1985-08-16 | KPE | Traditional | Advance Medical Designs, Inc. |
| K852778 | 1985-08-16 | KPE | Traditional | Advance Medical Designs, Inc. |
| K850959 | 1985-04-09 | JAA | Traditional | Advance Medical Designs, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1980 |
|---|---|
| Factory area | 130240 square meters |
| Main products | Guest room accessories, Dining supplies, Bedding, Personal care products, Hospitality supplies |
| Export markets | Asia-Pacific |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Medical Distribution Industries, Ltd. | 27 |
| Gaboss International Limited | 9 |
| Sunstar Trading International Limited | 6 |
| Sunrise Dental Laboratory, Ltd. | 5 |
| Polygreen (HK) Co., Ltd. | 4 |
| P. Gopaldas Ltd. | 2 |
| Daka International Limited | 2 |
| Profit Royal Pharmaceutical Limited | 2 |
| Kotex Development Holidings Ltd | 1 |
| Polystar Technology Development Limited | 1 |
| HK Damisen Technology Co., Limited | 1 |
| Mega Trade International Industrial Ltd | 1 |
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.