ISO 13485 CE FDA Certified OEM Adult Diaper
Partner with a medical-grade manufacturer holding full ISO 13485, ISO 9001, CE, and FDA certifications. Our factory offers complete OEM/ODM customization for adult disposable diapers, from private label packaging to custom material formulations. Ideal for hospital procurement, government tenders, and healthcare distributors worldwide.
Why Choose Our OEM Service
- ISO 13485 Certified: Medical device quality management system for regulatory compliance
- CE + FDA Registered: Ready for EU and US market entry
- Full Customization: Logo printing, custom packaging design, material specification
- Free Samples: 5-piece evaluation pack shipped within 48 hours via DHL/FedEx
- Dedicated Sample Coordinator: Technical support and tracking throughout evaluation
- 8 Million Pcs/Month Capacity: Reliable supply for large-volume orders
- Multiple Backsheet Options: PE film, cloth-like non-woven, breathable microporous
- Flexible SAP Options: Japan Sumitomo, Nippon Shokubai, or domestic SAP grades
Certification Details
| Certification |
Scope |
| ISO 13485:2016 |
Medical Device Quality Management |
| ISO 9001:2015 |
Quality Management Systems |
| CE Mark |
EU Medical Device Directive Compliance |
| FDA |
US Food Administration Registration |
Try-before-you-commit program available. Contact our OEM sales team for technical specifications and factory audit scheduling.