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Data / Medical devices / South Korea / CNC Technologies

CNC Technologies: FDA-registered device maker in GWANGMYEONG-SI Gyeonggi, South Korea, 2 510(k) clearances

CNC Technologies is registered with the FDA (registration 3009486890) in GWANGMYEONG-SI Gyeonggi, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009486890
Address
E1101, Gwang Myeong Technopark, 60, Haan-Ro, GWANGMYEONG-SI Gyeonggi, South Korea, 14322
Owner or operator
CnC Technologies (10087559)
Roles
Manufacturer
First device listed
March 14, 2023
Registered through
2026
Brand names listed
Duoblade (Models: DB1SEP, DB1SEP-H, DB1SEP-T, DB1SEP-TH), Duoblade (Models: DB1SP, DB1SP-H, DB1SP-T, DB1SP-TH)

Devices it lists

DeviceProduct codeClassRoleSource
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.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
August 11, 2025K252211Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)GEISubstantially EquivalentCnc Technologiesaccessdata.fda.gov
February 3, 2023K220996DuobladeGEISubstantially EquivalentCnc Technologiesaccessdata.fda.gov

Compare with other makers

Updated August 11, 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.