Data / Medical devices / China / Shanghai Kohope Medical Devices Co., Ltd
Shanghai Kohope Medical Devices Co., Ltd: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Shanghai Kohope Medical Devices Co., Ltd is registered with the FDA (registration 3009077131) in Shanghai, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009077131
- Address
- 1001, Building 2, Lane 2888 South QIlianshan Road, Shanghai, China, 200333
- Owner or operator
- Shanghai Kohope Medical Devices Co., Ltd (10051744)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 1, 2021
- Registered through
- 2026
- Brand names listed
- Cap, hypodermic syringe with/without needle, sterile insulin syringe for single use, with needle, syringe connector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Catheter | GCD | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 12, 2019 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use | FMF | Substantially Equivalent | Shanghai Kohope Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Disposable
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Connector, Catheter
Updated September 12, 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.