Shanghai Kohope Medical Devices Co., Ltd.
Registered establishment in Shanghai, China. 4 device types, 1 clearance.
Shanghai Kohope Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Connector, Catheter and 2 other device types. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009077131 |
| FEI number | 3009077131 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 上海科宏醫療器械有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 1001, Building 2, Lane 2888 |
| Postal code | 200333 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Connector, Catheter | Class 1 | syringe connector | 2022 | 15 |
| Instrument, Surgical, Disposable | Class 1 | Cap | 2021 | 45 |
| Needle, Hypodermic, Single Lumen | Class 2 | hypodermic syringe with/without needle, sterile insulin syringe for single use, with needle | 2021 | 71 |
| Syringe, Piston | Class 2 | hypodermic syringe with/without needle, sterile insulin syringe for single use, with needle | 2021 | 60 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K190002 | 2019-09-12 | FMF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Main products | Syringes, Needles, Blood collection sets, Infusion sets |
| Certifications | CE, ISO 13485 |
| Export markets | 50+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.