Shandong Ming Yuan Latex Achieves EU MDR CE Certification by TÜV Rheinland

[SHANDONG, CHINA] — Leading condom manufacturer Shandong Ming Yuan Latex Co., Ltd. is proud to announce it has officially received the EU Medical Device Regulation (EU) 2017/745 (MDR) Quality Management System Certificate. This certification was issued by the prestigious Notified Body TÜV Rheinland (0197).

The certificate (Registration No. HZ 2513793-1) verifies that the company’s quality management system for Class IIb Male Contraceptive Condoms meets the stringent safety and performance requirements of Annex IX

Key Certification Details:

• Manufacturer: Shandong Ming Yuan Latex Co., Ltd.

• EUDAMED SRN: CN-MF-000045347

• EU Representative: BioDomi GmbH

• Product Category: U110101 Male Contraceptive Devices (Condoms)

• Validity: Effective from May 16, 2025, until May 15, 2030

This milestone solidifies Shandong Ming Yuan's position as a top-tier OEM/ODM partner in the global medical device industry, ensuring our European partners receive products that adhere to the highest international standards.

Please visit the link of our CE certificate if you are interest:

https://www.certipedia.com/certificates/HZ+2513793-1?locale=en