인증 및
인허가 현황
BRITZMEDI operates under a strictly certified Quality Management System (QMS) and holds key regulatory approvals for its major products.
품질 및 인허가 인증
폭넓은 인증 체계를 통해 품질과 환자 안전에 대한 당사의 의지를 입증합니다.
FDA 510(k)
U.S. Food and Drug Administration 510(k) Clearance
FDA가 기존에 합법적으로 유통 중인 제품과의 실질적 동등성(Substantial Equivalence)을 인정한 510(k) 인증입니다.
ISO 13485:2016
Medical Device Quality Management Systems
Certified for the design, development, manufacture, and sales of active medical devices (Electrosurgical unit).
GMP
Good Manufacturing Practice
Manufacturing facilities certified by the Ministry of Food and Drug Safety (MFDS), Korea for medical device production.
MFDS License
Korea Ministry of Food and Drug Safety Manufacturing License
Official manufacturing license for medical devices issued by MFDS.
MFDS Certification
Korea Ministry of Food and Drug Safety Product Certification
Product certification for medical devices from MFDS.
KC (EMC)
Korea Certification - Electromagnetic Compatibility
Broadcasting and Communication Equipment registration for EMC compliance.
Venture Enterprise
Venture Enterprise Certification (R&D Type)
Recognized as a technology-intensive venture company focused on R&D innovation.
기술 안전 표준
당사 장비는 엄격한 국제 안전 표준에 따라 설계·시험되며, TORR RF는 FDA 510(k) 및 MFDS(식약처) 심사, ULBLANC은 MFDS(식약처) 인증 과정에서 이를 검증받았습니다.
전원 사양
Electrical Safety
General requirements for basic safety and essential performance of medical electrical equipment
EMC (Electromagnetic Compatibility)
Requirements and tests for electromagnetic disturbances and immunity
RF Safety
Particular requirements for high frequency surgical equipment and high frequency surgical accessories
Biocompatibility
Biological evaluation of medical devices - all patient-contacting materials are biocompatible
인허가 로드맵
BRITZMEDI 제품을 전 세계 시장에 선보이기 위한 인허가 확대 계획입니다.
| 지역 / 기관 | 제품 | 상태 | 비고 |
|---|---|---|---|
| Korea (MFDS) | TORR RF | Approved | - |
| ULBLANC | Approved | ||
| LUMINO WAVE | Under Review Target: H2 2026 | ||
| USA (FDA) | TORR RF | 510(k) Cleared | - |
| Europe (CE MDR) | All Medical Devices | In Preparation | Preparing for CE MDR certification |
| Brazil (ANVISA) | TORR RF | Planned | To follow FDA market stabilization |
| China (NMPA) | TORR RF | Planned | To follow FDA and CE market stabilization |
FDA 510(k) 인증 관련 안내
"FDA Cleared(인증)"는 FDA가 해당 기기를 기존에 합법적으로 유통 중인 제품과 실질적으로 동등하다고 판단했음을 의미하며, 고위험(3등급) 기기에 적용되는 PMA 절차인 "FDA 승인(Approval)"과는 다릅니다.