Shanghai Heyi Medical Instruments Co., Ltd.
Registered establishment in Shanghai, China. 4 device types.
Shanghai Heyi Medical Instruments Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Endoscopic Bite Block, Endoscope Channel Accessory and 2 other device types. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009064553 |
| FEI number | 3009064553 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 上海和一医疗仪器有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN |
| Postal code | 200041 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Disposable Cleaning Brushes | 2017 | 43 |
| Endoscope Channel Accessory | Class 2 | Disposable Endoscope Valves Set A | 2017 | 21 |
| Endoscopic Bite Block | Class 1 | Disposable Bite Blocks | 2017 | 44 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Disposable Injection Needle | 2017 | 23 |
Clearances
No clearance names Shanghai Heyi Medical Instruments Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K151714 | 2015-12-03 | ODC | Traditional | Wilson Instruments (Shanghai) Company Limited |
| K142144 | 2015-01-15 | FBK | Traditional | Wilson Instruments (Shanghai) Company Limited |
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.