The SUNGO brand was founded in 2006, determined to become an international technical service provider on medical device regulations. SUNGO currently has service organizations in China, Europe, North America and Australia, and the customers it has served cover Asia (China, Vietnam, Malaysia, Bangladesh and Singapore), Europe (UK, Switzerland, Sweden, Denmark and Norway), North America (US and Canada), South America (Argentina), Oceania (Australia), Africa (Botswana and South Africa) and other countries and regions.
SUNGO is committed to providing market access compliance consulting and international registration services for medical device manufacturers and operators worldwide. It provides a full range of technical support for companies in terms of production, testing, process management, registration, certification, rectification, and listing follow-up, to escort product compliance and successful listing. For over ten years, SUNGO has provided related services for more than 30 listed companies and world-renowned device manufacturers, totaling more than 5,000 enterprises.
SUNGO always pursues professional support, quality service and customer satisfaction. Professional customer service staffs of SUNGO provide one-to-one service for all customers, maintain regular contact with customers, provide immediate online service, provide all-around professional support, and solve problems in the aspect of technical barrier existing in trading.
SUNGO is a long-term strategic partner providing professional technical support rather than a one-off partner. We will uphold the principle of “professional service and customer orientation” and rely on professional technical teams to optimize our services, so that more medical devices can enter the market legally and safely, and to contribute to the healthy development of the medical device industry.
Assurance through professionalism!
SUNGO Europe B.V. was registered in Amsterdam in 2017. The service team in SUNGO Europe B.V. could use the language of Dutch, English and Chinese to deliver the service to the global clients. We also have professional background on the medical device industry and the legislation of European.
The main activity of SUNGO Europe B.V.
includes:
· Keep communication with the client and the competence authority
· Respond to any enquiry from the interested party
· Support to the competence authority when necessary
· Keep the client’s technical files according to the directive and regulation
· Complete the device registration as the EU REP of the manufacturer
· To be an active role in the post market surveillance of the device
To get in touch with us, you may
· Send mail to Ec.rep@sungoglobal.com for general enquiry if you are existed clients.
· Send mail to info@sungoglobal.com for enquiry if you are potential clients.
· For urgent needs, please call us at +31(0)202111106.
· If you want to set up a face to face meeting with us in Netherlands, please call us one week before the destinated meeting date.
SUNGO Certification Company Limited was
registered in London in 2013. The service team in SUNGO Certification Company
Limited could use the language of English and Chinese to deliver the service to
the global clients. We also have professional background on the medical device
industry and the legislation of European.
The main activity of SUNGO Certification Company Limited includes:
· Keep communication with the client and the competence authority
· Respond to any enquiry from the interested party
· Support to the competence authority when necessary
· Keep the client’s technical files according to the directive and regulation
· Complete the device registration as the UK Responsible Person of the manufacturer
· To be an active role in the post market surveillance of the device
To get in touch with us, you may
· Send mail to Ec.rep@sungogroup.com for general enquiry if you are existed clients.
· Send mail to info@sungoglobal.com for enquiry if you are potential clients.
· For urgent needs, please call us at +44 (0) 7868234015.
· If you want to set up a face to face meeting with us in the UK, please call us one week before the destinated meeting date.
SUNGO Cert GmbH was registered in
Dusseldorf in 2018. The service team in SUNGO Cert GmbH could use the language
of English and Chinese to deliver the service to the global clients. We also
have professional background on the medical device industry and the legislation
of European.
The main activity of SUNGO Cert GmbH includes:
· Keep communication with the client and the competence authority
· Respond to any enquiry from the interested party
· Support to the competence authority when necessary
· Keep the client’s technical files according to the directive and regulation
· Complete the device registration as the EU REP of the manufacturer
· To be an active role in the post market surveillance of the device
To get in touch with us, you may
· Send mail to de.rep@sungolgobal.com for general enquiry if you are existed clients.
· Send mail to info@sungoglobal.com for enquiry if you are potential clients.
For urgent needs, please call us at +49 (0) 211 97634133.
· If you want to set up a face to face meeting with us in Germany, please call us one week before the destinated meeting date.
SUNGO Australia was registered in Melbourne in 2018. The service team in SUNGO Australia could use the language of English and Chinese to deliver the service to the global clients. We also have professional background on the medical device industry and the legislation of Australia.
The main activity of SUNGO Australia
includes:
· Keep communication with the client and the competence authority
· Respond to any enquiry from the interested party
· Support to the competence authority when necessary
· Keep the client’s technical files according to the directive and regulation
· Complete the registration as the Temporary Sponsor or Agent of the manufacturer
· To be an active role in the post market surveillance of the device
To get in touch with us, you may
· Send mail to Australia@sungoglobal.com for general enquiry if you are existed clients.
· Send mail to info@sungoglobal.com for enquiry if you are potential clients.
· For urgent needs, please call us at +61 436 484 766.
· If you want to set up a face to face meeting with us in Australia, please call us one week before the destinated meeting date.
SUNGO Technical Service Inc. was registered in US in 2013. The service team in SUNGO Technical Service Inc. could use the language of English and Chinese to deliver the service to the global clients. We also have professional background on the medical device industry and the legislation of US and Canada.
The main activity of SUNGO Technical
Service Inc. includes:
· Keep communication with the client and the competence authority
· Respond to any enquiry from the interested party
· Support to the competence authority when necessary
· Submit the registration application to US FDA or Health Canada
· Complete the device registration as the US agent of the manufacturer
To get in touch with us, you may
· Send mail to us.fda@sungolgobal.com for general enquiry if you are existed clients.
· Send mail to info@sungoglobal.com for enquiry if you are potential clients.
· For urgent needs, please call us at +1 855 957 7779.
· If you want to set up a face to face meeting with us in Netherlands, please call us one week before the destinated meeting date.
