U&u Medical Technology Co., Ltd
hongkong, HK
U&U MEDICAL TECHNOLOGY CO., LTD appears in FDA device records in hongkong, HK. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for U&u Medical Technology Co., Ltd between 2013 and 2019. The busiest year on record is 2015, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181508 | U&U Blood Collection Sets | FMI | Substantially Equivalent | |
| K171823 | U&U Indicator tape and strip | JOJ | Substantially Equivalent | |
| K160855 | U&U Enteral Syringe | PNR | Substantially Equivalent | |
| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | Substantially Equivalent | |
| K151151 | U & U Intravascular Administration Set | FPA | Substantially Equivalent | |
| K143637 | U&U Sterilization Pouch and Roll | FRG | Substantially Equivalent | |
| K143629 | U&U Bowie-Dick Test Pack | JOJ | Substantially Equivalent | |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K123162 | U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL | FRG | Substantially Equivalent | |
| K132552 | U&U STERILE HYPODERMIC NEEDLE | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014456066 | 3014456066 | U&U MEDICAL TECHNOLOGY CO., LTD | RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN ,, hongkong 11702 HK | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PNREnteral Syringes With Enteral Specific Connectors
- JOJIndicator, Physical/Chemical Sterilization Process
- KDCInstrument, Surgical, Disposable
- GAANeedle, Aspiration And Injection, Disposable
- DZMNeedle, Dental
- FMINeedle, Hypodermic, Single Lumen
- FPASet, Administration, Intravascular
- MEGSyringe, Antistick
- EIBSyringe, Irrigating (Dental)
- FMFSyringe, Piston
- GAXTourniquet, Nonpneumatic
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets U&u Medical Technology Co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain