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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

DeviceProduct codeClassRoleSource
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 7, 2025K242207NOABLE LASERGEXSubstantially EquivalentDaeju Meditech Engineering Co., Ltd.accessdata.fda.gov
September 27, 2024K242206ACTIVOGEXSubstantially EquivalentDaeju Meditech Engineering Co., Ltd.accessdata.fda.gov
September 3, 2021K211637AROMA GRANDGEXSubstantially EquivalentDaeju 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.