Data / Medical devices / China / Ming Fai Enterprise International Co., Ltd
Ming Fai Enterprise International Co., Ltd: FDA-registered device maker in Kowloon, Hong Kong, China, 9 510(k) clearances
Ming Fai Enterprise International Co., Ltd is registered with the FDA (registration 3007143236) in Kowloon, Hong Kong, China. It lists 18 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 25, 2017. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007143236
- Address
- Unit D3, 8/F, TML Tower, No 3 Hoi Shing Rd Tsuen Wan, New Territories, Kowloon, Hong Kong, China, -
- Owner or operator
- Ming Fai Enterprise International Co., Ltd. (9035380)
- Roles
- Exporter to the US
- First device listed
- April 30, 1998
- Registered through
- 2027
- Brand names listed
- 3-Ply Disposable Face Mask, ADHESIVE BANDAGE, Bag Decanter, Bottle Decanter, COTTON SWAB, Cotton ball / Cotton pad, DENTAL FLOSS, Drape Surgical and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 25, 2017 | K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | MUI | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| October 30, 2001 | K011265 | ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| September 18, 2001 | K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | KKX | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| January 26, 2001 | K003670 | PATIENT DRAPE, SURGICAL | KKX | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| September 20, 1985 | K852893 | VIAL DECANTER | KPE | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| August 21, 1985 | K853188 | TRANSFER DEVICE | LHI | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| August 16, 1985 | K852778 | BOTTLE DECANTER | KPE | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| August 16, 1985 | K852777 | BAG DECANTER | KPE | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| April 9, 1985 | K850959 | EQUIPMENT SNAP KOVERS | JAA | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, I.V.
- All makers of Drape, Surgical, Antimicrobial
- All makers of Personal Protection Kit
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Bedding, Disposable, Medical
- All makers of Protector, Skin Pressure
Updated October 25, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.