Data / Medical devices / China / Shanghai Heyi Medical Instruments Co., Ltd.
Shanghai Heyi Medical Instruments Co., Ltd.: FDA-registered device maker in Shanghai, China, 2 510(k) clearances
Shanghai Heyi Medical Instruments Co., Ltd. is registered with the FDA (registration 3009064553) in Shanghai, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 3, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009064553
- Address
- 25D, Heyi Business Plaza, No. 420 Jiangning Rd.,jingan, Shanghai, China, 200041
- Owner or operator
- SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD. (10056224)
- Roles
- Exporter to the US
- First device listed
- November 16, 2017
- Registered through
- 2026
- Brand names listed
- Disposable Bite Blocks, Disposable Cleaning Brushes, Disposable Endoscope Valves Set A, Disposable Injection Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Exporter to the US | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Exporter to the US | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Exporter to the US | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 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 |
|---|---|---|---|---|---|---|
| December 3, 2015 | K151714 | Disposable Endoscope Valves Set A | ODC | Substantially Equivalent | Wilson Instruments (Shanghai) Company Limited | accessdata.fda.gov |
| January 15, 2015 | K142144 | DISPOSABLE INJECTION NEEDLE | FBK | Substantially Equivalent | Wilson Instruments (Shanghai) Company Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Injection Needle, Gastroenterology-Urology
- All makers of Endoscope Channel Accessory
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Endoscopic Bite Block
Updated December 3, 2015. 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.