Data / Medical devices / Taiwan / Lagis Enterprise Co., Ltd.
Lagis Enterprise Co., Ltd.: FDA-registered device maker in Dajia Dist, Taichung City, Taiwan, 3 510(k) clearances
Lagis Enterprise Co., Ltd. is registered with the FDA (registration 3007185043) in Dajia Dist, Taichung City, Taiwan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007185043
- Address
- No. 29, Gong 1st Rd, Dajia Dist, Taichung City, Taiwan, 437
- Owner or operator
- Lagis Enterprise Co., Ltd (10029993)
- Roles
- Manufacturer
- First device listed
- November 27, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 20, 2026 | K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | GEI | Substantially Equivalent | Lagis Enterprise Co., Ltd. | accessdata.fda.gov |
| March 17, 2025 | K243867 | LAGIS Suction Irrigation System | GCJ | Substantially Equivalent | Lagis Enterprise Co., Ltd. | accessdata.fda.gov |
| October 30, 2024 | K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | GCJ | Substantially Equivalent | Lagis Enterprise Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated May 20, 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.