Shenzhen PACOM Medical Devices Company is a Class II medical device manufacturer specialising in electronic
thermometers, infrared thermometers and breast pumps, the company started to apply for CE certification from 2017,
the notified body is CE0598.
Following the ISO 13485 quality system certification approved by SGS 0120, the company submitted an application
for CE registration of electronic thermometers and infrared thermometers.
During the audit, SGS Finland assigned a German auditor to audit TCF and a Finnish clinician to audit CER.
In our company's professional level of CE TCF preparation, we passed the auditor's review in time, and finally
successfully obtained the CE certificate.


