SPECTRABABY

Research Center

R & D CENTER

Uzin Medicare will strengthen product competitiveness
through the best researchers and advanced R&D.

FDA certifications

FDA
510(K) Premarket Notification
CE certifications

EC Certificate
Full Quality Assurance System
ISO certifications

ISO 13485:2016
FDA certifications

Establishment Registration
Breast pump
FDA certifications

Establishment Registration
UV-Sterilizers (for baby bottle)
FDA certifications

FDA
510(K) Premarket Notification
FDA certifications

FDA
510(K) Premarket Notification
FDA certifications

FDA
510(K) Premarket Notification
GMP certifications

Medical instrument manufacturing and quality management standard computability certificate

Category	Contents	Remarks
Certificate of analysis	Baby Bottle	Spectra all new baby bottle Bisphenol S free MORE VIEW
Certificate of analysis	Baby bottle	European standard EU10/2011 MORE VIEW
Certificate of analysis	Baby Bottle UV Sterilizer	Baby bottle sterilizer pneumonia bacillus disinfection report card MORE VIEW
Certificate of analysis	Baby Bottle UV Sterilizer	Baby Bottle Disinfector disinfection report card MORE VIEW
Certificate of analysis	Baby Bottle UV Sterilizer	Baby Bottle Disinfector disinfection report card MORE VIEW
Patents	Breast Pump	Air current blocking materials for breast pumps and breast pump equipped with this
Patents	Breast Pump	Noise reduction device and breast pump pressure adjustment device equipped with this
Patents	Breast Pump	Breast Pump
Trademark registration certificate	Type 10	5 cases such as Breast Pump MORE VIEW
Trademark registration certificate	Type 11	14 cases such as Baby Bottle Disinfector MORE VIEW