DongYang SongPu Latex Obtains TÜV Rheinland EU MDR CE Certificate for Condoms
JINZHOU, LIAONING, CHINA – DongYang SongPu Latex (Jinzhou) Co., Ltd. is pleased to announce that it has successfully passed comprehensive audits by TÜV Rheinland LGA Products GmbH, a notified body (NB 0197) designated under EU medical device regulations, and obtained the EU Quality Management System CE Certificate complying with Regulation (EU) 2017/745 (MDR) Annex IX. The certification covers our Class IIb medical device: U110101 Male Contraceptive Devices – Condoms, granting full legal market access across all EU member states.
Core Certificate Information
- Issuing Notified Body: TÜV Rheinland LGA Products GmbH, Tillystraße 2, 90431 Nürnberg, Germany (NB No. 0197)
- Governing Regulation: REGULATION (EU) 2017/745 (MDR), Annex IX Chapter I Sections 2 & 3, Chapter III
- Certificate Registration No.: HZ 2505594-1
- EUDAMED Single Registration Number (SRN): CN-MF-000036502
- Audit Report No.: 190148202-120
- Revision: 0 (Initial Certification)
- Issue Date / Effective Date: 13 May 2024
- Expiry Date: 12 May 2029
- EU Authorized Representative: Shanghai International Holding Corp. GmbH (Europe), Eiffestrasse 80, 20537 Hamburg, Germany
- Manufacturer Facility: DongYang SongPu Latex (Jinzhou) Co., Ltd., New and High-tech Development Zone, Jinzhou 121000, Liaoning, P.R. China
The official statement issued by TÜV Rheinland confirms that DongYang SongPu Latex has established and fully implemented a complete MDR-compliant quality management system subject to annual surveillance audits. All mandatory requirements of Annex IX Chapter I, Section 3 and Annex IX Chapter III have been fully fulfilled. As Class IIb medium-risk medical devices, condoms face far stricter oversight under MDR compared with the obsolete MDD directive, covering raw latex material safety, biocompatibility testing, batch traceability, risk management, post-market vigilance and complete technical documentation.
Our cross-functional team of R&D, quality assurance, production and regulatory affairs completed multiple rounds of system optimization, documentation compilation and on-site rectification, and passed the full-spectrum assessment in one go. Every link from incoming raw material inspection, automated production, finished-product physical performance testing to after-sales adverse event handling now meets EU medical-grade standards.
Significance of MDR CE Certification
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Full EU Market Access EligibilityWith valid MDR CE certification and completed EUDAMED manufacturer registration, our condom products can be legally circulated and sold in all EU/EEA countries without repetitive national certification procedures, greatly simplifying channel development for European distributors, pharmacies and retail chains.
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Authoritative Global Quality Endorsement & Competitive EdgeTÜV Rheinland is one of the world’s most recognized third-party certification bodies for medical devices. This MDR certificate serves as credible proof that our quality control and product safety benchmarks match Europe’s highest medical device criteria, creating differentiated advantages in global OEM & ODM cooperation negotiations.
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Solid Foundation for Global LayoutThe standardized MDR compliance system supports our expansion plan targeting Europe, while also facilitating market entry into Middle East, Southeast Asia, Latin America and other regions that recognize EU CE-MDR credentials. The company will continuously expand market share of Chinese-manufactured latex contraceptive medical devices worldwide.
