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Data / Medical devices / South Korea / Britzmedi Co., Ltd.

Britzmedi Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 1 510(k) clearance

Britzmedi Co., Ltd. is registered with the FDA (registration 3029916132) in Seongnam-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3029916132
Address
#1211, 12F, 388 Dunchon-daero Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13403
Owner or operator
Britzmedi Co., Ltd. (10088936)
Roles
Manufacturer
First device listed
October 23, 2023
Registered through
2026
Brand names listed
Electrosurgical, cutting & coagulation & accessories, MTX-C1, TORR RF

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
September 27, 2022K212561MTX-C1GEISubstantially EquivalentIlooda Co,., Ltd.accessdata.fda.gov

Compare with other makers

Updated September 27, 2022. 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.