Сертификация и
регуляторный статус
BRITZMEDI operates under a strictly certified Quality Management System (QMS) and holds key regulatory approvals for its major products.
Сертификаты качества и регуляторного соответствия
Наши комплексные сертификаты подтверждают нашу приверженность качеству и безопасности пациентов.
FDA 510(k)
U.S. Food and Drug Administration 510(k) Clearance
FDA has determined the device to be substantially equivalent to a legally marketed predicate device for indications including temporary relief of muscle pain and temporary reduction in the appearance of cellulite.
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.
Стандарты технической безопасности
Наши устройства разработаны и протестированы в соответствии со строгими международными стандартами безопасности, что подтверждено в процессе проверки FDA 510(k) и MFDS.
Требования к электропитанию
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
Регуляторная дорожная карта
Наши текущие усилия по выводу продукции BRITZMEDI на мировые рынки.
| Регион / Агентство | Продукт | Статус | Примечания |
|---|---|---|---|
| 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 | Transitioning from MDD to MDR |
| Brazil (ANVISA) | TORR RF | Planned | To follow FDA market stabilization |
| China (NMPA) | TORR RF | Planned | To follow FDA and CE market stabilization |
Важное примечание о допуске FDA
"FDA Cleared" indicates the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. It does not denote "FDA Approval," which is reserved for high-risk (Class III) devices requiring PMA.
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