Data / Medical devices / China / Nanjing Topwin Co., Ltd.
Nanjing Topwin Co., Ltd.: FDA-registered device maker in Nanjing Jiangsu, China, 6 510(k) clearances
Nanjing Topwin Co., Ltd. is registered with the FDA (registration 3030171742) in Nanjing Jiangsu, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 14, 2022. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030171742
- Address
- Building 2, No. 388 East Tianyuan Road, Jiangning District, Nanjing, Nanjing Jiangsu, China, 210012
- Owner or operator
- Nanjing Topwin Co., Ltd. (10091192)
- Roles
- Exporter to the US
- First device listed
- July 21, 2024
- Registered through
- 2027
- Brand names listed
- CareLiving, Comfort Touch, Easylife, Quick Touch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Exporter to the US | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Exporter to the US | accessdata.fda.gov |
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 14, 2022 | K213183 | Safety Insulin Pen Needles | FMI | Substantially Equivalent | Zhejiang Kindly Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 19, 2022 | K221839 | Lancet | FMK | Substantially Equivalent | Hebei Xinle Sci&Tech Co., Ltd. | accessdata.fda.gov |
| July 1, 2022 | K221176 | Insulin Pen Needle | FMI | Substantially Equivalent | Tianjin Huahong 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 |
| February 28, 2012 | K111456 | MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Tianjin Empecs Medical Device Co., Ltd. | accessdata.fda.gov |
| December 9, 2005 | K052208 | GLUCOSE PILOT | NBW | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Antistick
- All makers of Syringe, Piston
Updated October 14, 2022. 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.