Data / Medical devices / South Korea / Woorhi Mechatronics
Woorhi Mechatronics: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 1 510(k) clearance
Woorhi Mechatronics is registered with the FDA (registration 3010126182) in Gunpo-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010126182
- Address
- 5th Floor Woorhi Mecha Building 58 San bon-ro 48 beon-gil, Gunpo-si Gyeonggi, South Korea, 15846
- Owner or operator
- Woorhi Mechatronics (10093681)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 23, 2025
- Registered through
- 2026
- Brand names listed
- CODE-X, Needle Cartridge, DP 4, DP 4 Needle Cartridge, Dermapen 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Contract manufacturer, 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 13, 2026 | K252591 | Automatic Micro Needle System (CODE-X) | QAI | Substantially Equivalent | Woorhi Mechatronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 13, 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.