Data / Medical devices / Hong Kong / U&u Medical Technology Co., Ltd
U&u Medical Technology Co., Ltd: FDA-registered device maker in hongkong, Hong Kong, 10 510(k) clearances
U&u Medical Technology Co., Ltd is registered with the FDA (registration 3014456066) in hongkong, Hong Kong. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 13, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014456066
- Address
- RM C1-D 6/F Wing Hing Ind BLDG 14 Hing Yip ST Kwun Tong KLN, hongkong, Hong Kong, 11702
- Owner or operator
- U&U Medical Technology Co., Ltd (10057703)
- Roles
- Exporter to the US, Specification developer
- First device listed
- May 15, 2018
- Registered through
- 2027
- Brand names listed
- Blunt Needle Plastic, Dental Needle, Dental Syringe, ENTERAL SYRINGE, INFUSION SETS, Insulin syringe, MERIT SYRINGE CAP, NEEDLE 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 |
|---|---|---|---|---|---|---|
| February 13, 2019 | K181508 | U&U Blood Collection Sets | FMI | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| November 22, 2016 | K160855 | U&U Enteral Syringe | PNR | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| March 25, 2016 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| September 24, 2015 | K151151 | U & U Intravascular Administration Set | FPA | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| September 9, 2015 | K143637 | U&U Sterilization Pouch and Roll | FRG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| August 11, 2015 | K142765 | TM SAFETY NEEDLE | FMI | Substantially Equivalent | Thinkmed Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 29, 2014 | K131954 | MEDI PEN NEEDLE | FMI | Substantially Equivalent | Shanghai Carelife International Trading Co. , Ltd. | accessdata.fda.gov |
| February 27, 2014 | K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | FMF | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| November 13, 2013 | K132552 | U&U STERILE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| June 10, 2011 | K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | FMF | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Syringe, Irrigating (Dental)
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Enteral Syringes With Enteral Specific Connectors
Updated February 13, 2019. 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.