Data / Medical devices / Laparoscope, General & Plastic Surgery / Taiwan
FDA-registered makers of Laparoscope, General & Plastic Surgery in Taiwan: 7 establishments
7 establishments in Taiwan are registered with the FDA to make Laparoscope, General & Plastic Surgery (product code GCJ). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Laparoscope, General & Plastic Surgery
- Product code
- GCJ
- Country
- Taiwan
Makers of Laparoscope, General & Plastic Surgery in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Taiwan Surgical Corporation | Zhubei City Hsinchu(County), Taiwan | Manufacturer | 3 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Unimax Medical Systems Inc. | New Taipei City, Taiwan | Exporter to the US, Specification developer | 3 | October 17, 2011 | 0 | 1 | 0 | api.fda.gov |
| Unimax Medical Systems Inc. | Yilan County, Taiwan | Manufacturer | 3 | October 17, 2011 | 0 | 0 | 0 | api.fda.gov |
| Lagis Enterprise Co., Ltd. | Dajia Dist, Taichung City, Taiwan | Manufacturer | 2 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Design Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Altek Biotechnology Corporation | Hsinchu Hsinchu(City), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract 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.