Data / Medical devices / Insufflator, Laparoscopic / China
FDA-registered makers of Insufflator, Laparoscopic in China: 8 establishments
8 establishments in China are registered with the FDA to make Insufflator, Laparoscopic (product code HIF). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Insufflator, Laparoscopic
- Product code
- HIF
- Country
- China
Makers of Insufflator, Laparoscopic in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Guangdong Optomedic Technologies, Inc. | Foshan Guangdong, China | Manufacturer | 2 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 1 | January 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Kangji Medical Instrument Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 1 | May 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Surgnova Healthcare Technologies (zhejiang) Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | March 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Uwell Medical Device Manufacturing Co Ltd | Tianjin, China | Manufacturer | 1 | December 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Unimicro Medical Systems (shenzhen) Co., Ltd. | ShenZhen Guangdong, China | Manufacturer | 1 | July 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| Global Medical Production Co. Ltd | JiaXing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.