Good news: Shenzhen Pukang Company has obtained the CE certificate issued by SGS
Source: Success cases Edit: Reanny Medical Devices Management Consulting Co., Ltd. Read: 355 Date: 2024-06-18
Shenzhen Pukang Medical Equipment Co., Ltd. is a Class II medical device manufacturer specializing in the production of electronic thermometers, infrared thermometers, and breast pumps. The company has been applying for CE certification since 2017, and the notified body is CE0598
After obtaining ISO 13485 quality system certification approved by SGS 0120, the company submitted CE registration applications for electronic thermometers and infrared thermometers.
During the audit, SGS Finland assigned German auditors to audit TCF and Finnish clinical doctors to audit CER.
At the professional level of CE TCF writing in our company, we passed the auditor's review in a timely manner and finally successfully obtained the CE certificate.