MDR CE Approved Custom Condom Manufacturer for European Brands
With the transition from MDD to MDR, launching condoms in the European market has become more complex and highly regulated. As an MDR CE approved condom manufacturer, we support European brands with fully compliant, custom-made condoms, from formulation to private label packaging.
MDR CE Compliance – Designed for the European Market
Condoms belong to Medical Device Class IIb. They must comply EU MDR(EU 2017/745). We can provide you:
EU Certificate
ISO13485 Certificate
Declaration of Conformity
Certificate of Analysis
Technical Documents
Custom Condom Manufacturing Capabilities
Condom available size: 49mm, 52mm, 55mm
Material: Premium Quality Natural Latex Imported from Thailand
Lubricant: Silicone-Based Lubricant
Color: Natural color or Colored
Flavor: non-flavor or flavored
We’r not just OEMcondom Factory, but a long-term development partner.
From Inquiry to Market Launch, we have the professional regulatory & sales team which can make your business simple, clear and controllable.
If you are looking for a reliable MDR CE approved condom manufacturer for your European brand, contact us to discuss your private label or custom condom project.
Email: [email protected] / [email protected]
WhatsApp: 0086-191-5379-1397
Contact:Rita