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Enterprise Qualification
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At present, Genia has passed ISO 13485 international medical device quality management system certification, ISO 45001 occupational health and safety management system certification, ISO 14001 environmental management system certification, GB/T 29490 intellectual property management system certification, and safety production standardization certificate. The products have passed CE, NMPA, FDA, CB, FCC, ROHS, REACH and other certifications, and the product quality has been tested in 97 countries for a long time.

FDA(510K)

FDA(510K)

European CE Certification

European CE Certification

Medical Device MDR Certificate for Wireless Electronic Thermomete

Medical Device MDR Certificate for Wireless Electronic Thermomete

Medical Device MDR Certificate for Pulse Oximeter

Medical Device MDR Certificate for Pulse Oximeter

ISO13485

ISO13485

BSCI(Business Social Compliance Initiative)

BSCI(Business Social Compliance Initiative)

Medical device manufacturing license

Medical device manufacturing license

Class A medical device manufacturer

Class A medical device manufacturer

ISO45001

ISO45001

ISO14001

ISO14001

Intellectual property management system certification

Intellectual property management system certification

Infrared forehead thermometer CB certification

Infrared forehead thermometer CB certification

Blood Pressure Monitor Metrology Accreditation

Blood Pressure Monitor Metrology Accreditation

Infrared Thermometer Metrology Accreditation

Infrared Thermometer Metrology Accreditation

Digital Thermometer RoHS

Digital Thermometer RoHS

BV production capacity depth certification

BV production capacity depth certification

Digit Thermometer FCC

Digit Thermometer FCC

Infrared forehead thermometer FCC certification

Infrared forehead thermometer FCC certification

Infrared forehead thermometer RoHS certification

Infrared forehead thermometer RoHS certification

Wrist Blood Pressure Monitor FCC certification

Wrist Blood Pressure Monitor FCC certification