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neobiotech

Quality

Neobiotech’s quality management emphasizes the protection of public health and welfare in the interest of our global community and therefore, ensures good quality management systems.

By complying with international laws and regulations in the field of medical industry, we maintain high quality standards for our products and services.

Certifications & Registrations
Russia Certificate
US FDA 510(k) Certificate
Japan JPAL Certificate
China CFDA Certificate
Canada CMDCAS Certificate

CE MDD Certificate; 2020 Certificate

CE MDD Certificate; 2020 Certificate

ISO9001; 2020 Certificate

ISO9001; 2020 Certificate

ISO13485; 2020 Certificate

ISO13485; 2020 Certificate

US FDA 510(K) Letter_K190849

US FDA 510(K) Letter
K190849
IS-lll active System_S-Narrow Type

US FDA 510(K) Letter_K181178

US FDA 510(K) Letter
K181178
S-Mini active Fixture

US FDA 510(K) Letter_K181138

US FDA 510(K) Letter
K181138
IS-lll active System

US FDA 510(K) Letter_K181137

US FDA 510(K) Letter
K181137
IT-lll active System

US FDA 510(K) Letter_K173938

US FDA 510(K) Letter
K173938
IS-lll HActive Fixture

US FDA 510(K) Letter_K160991

US FDA 510(K) Letter
K160991
Neo GBR System_Tent Screw

US FDA 510(K) Letter_K120503

US FDA 510(K) Letter
K120503
CMI Implant IS-ll active Fixture

US FDA 510(K) Letter_K113554

US FDA 510(K) Letter
K113554
CMI Implant IS System

US FDA 510(K) Letter_K112540

US FDA 510(K) Letter
K112540
S-Mini Implant System

US FDA 510(K) Letter_K111761

US FDA 510(K) Letter
K111761
CTi Mem System

US FDA 510(K) Letter_K090825

US FDA 510(K) Letter
K090825
IS System

US FDA 510(K) Letter_K090527

US FDA 510(K) Letter
K090527
IT System

US FDA 510(K) Letter_K090377

US FDA 510(K) Letter

K090377

EB System

Russia Certificate (CMI Implant System)

 

Russia Certificate (CTi-mem)

 

Russia Certificate (Instrument)

 

CFDA Certificate (Non-coating Abutment)