Data / Medical devices / South Korea / Daeju Meditech Engineering Co., Ltd.
Daeju Meditech Engineering Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 3 510(k) clearances
Daeju Meditech Engineering Co., Ltd. is registered with the FDA (registration 3020770009) in Seoul, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 7, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020770009
- Address
- #, HausD Sejong Tower, 26, Seongsu-il-ro 10-gil, Seoul, South Korea, 04793
- Owner or operator
- DAEJU MEDITECH ENGINEERING CO., LTD. (10083120)
- Roles
- Manufacturer
- First device listed
- October 26, 2021
- Registered through
- 2027
- Brand names listed
- ACTIVO, Aroma Grand, Noable Laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| March 7, 2025 | K242207 | NOABLE LASER | GEX | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. | accessdata.fda.gov |
| September 27, 2024 | K242206 | ACTIVO | GEX | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. | accessdata.fda.gov |
| September 3, 2021 | K211637 | AROMA GRAND | GEX | Substantially Equivalent | Daeju Meditech Engineering Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 7, 2025. 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.