
Shenzhen Combei Technology Co.,Ltd. Established in Taiwan and Shenzhen in 2007, we are one of the important manufacturers in the global household and medical device industry. Our core products include electronic blood pressure monitors, electronic thermometers and medical ultrasonic nebulizers. We focus on providing multi-brand OEM/ODM customized services for Chinese and global customers. With mature technology and manufacturing capabilities, we have become a trusted professional manufacturer for many partners. Relying on an outstanding quality control system, continuous innovative research and development capabilities, as well as the strict standards for "high accuracy and high reliability" in medical devices, we have established a good reputation in the industry. Particularly, we have accumulated rich experience in multiple categories of medical device OEM/ODM fields both domestically and internationally. We always integrate professional technology into product development, from blood pressure monitoring, body temperature measurement to respiratory assistance treatment equipment. Each product strives for accuracy and reliability. By providing high-quality health monitoring and treatment assistance tools, we aim to use technological innovation to contribute to safeguarding public health.
A reliable and accurate of the measured value is important to ensure the safety of self monitoring. For Combei instruments , measuring means measuring as accurately as a doctor would. Our medical devices are clinically validated and guarantee the highest level of safety.
The products of Combei have passed multiple authoritative compliance certifications, including the compliance certification of the EU Medical Device Regulation (MDR) (with CE marking), EN ISO 13485:2016 Medical Device Quality Management System Certification, and have completed the registration/approval of the US FDA and the certification of the National Medical Products Administration (NMPA) of China.
Registration with the US FDA: for upper arm BPM, k number k181104:https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181104.pdf
for wrist BPM, K number k171833:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K171833
Combei is not just a factory, Combei is a total solution partner.Combei’s competence in the R&D , TQE (Total Quality Efficiency) ESH 2018 validation for blood pressure monitor Ability & Acknowledge for ESH validation cooperated with authoritative institute Arm BPM and Wrist BPM have been validated by ESH 2018 Link to our paper on PubMed:
https://pubmed.ncbi.nlm.nih.gov/35309162/ https://www.dovepress.com/articles.php?article_id=73640.
approved by STRIDE BP and is now listed on its website: https://stridebp.org/bp-monitors
In the future we want to keep on doing together what we do best!
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