ABOUT RIVEX
Medical supplies from manufacturers you can trust.
We're a direct importer bridging the gap between ISO 13485 certified factories and American healthcare providers.
OUR STORY
Built for healthcare professionals
Rivex Medical was founded in 2026 to bridge the gap between ISO-certified manufacturers and American healthcare providers. The medical supply chain has a structural problem: too many intermediaries marking up products before they reach the clinic or hospital that actually needs them.
We work directly with factories — not distributors, not trading companies — to eliminate that markup without cutting corners on quality. Every facility we source from is vetted for ISO 13485 compliance, FDA registration, and ethical labor practices before we place a single order.
Our manufacturing partners operate from Zhejiang Province, China, one of the world's primary centers for medical disposable production. These facilities supply hospitals across 40+ countries. We own the supply chain relationship, which means full traceability from raw material to delivery — and no surprises on quality or lead times.
MILESTONES
Our Journey
Founded
Rivex Medical incorporated, initial supplier vetting begins.
FDA Registration
Establishment registration complete under 21 CFR Part 807.
First Orders
Initial product catalog launched with 9 FDA-registered SKUs.
Expansion
Building toward full catalog coverage for dental, medical, and clinical supply segments.
How We Source
Manufacturer Vetting
We audit factories for ISO 13485 certification, FDA registration, and ethical sourcing. Only facilities meeting our standards make the cut.
Quality Inspection
Every production lot undergoes AQL inspection before shipping. Certificate of Analysis available for every product.
US-Based Fulfillment
Products ship from US warehouses. Most orders ship same business day with tracking.
COMPLIANCE
Certifications & Compliance
FDA Registered
Rivex Medical is registered with the US Food and Drug Administration as a medical device establishment under 21 CFR Part 807. Our registration number is available upon request.
Learn more →ISO 13485:2016
Our manufacturing partners maintain ISO 13485:2016 certified quality management systems for medical devices — the global standard for device quality.
Learn more →CE Marked
Products meet European conformity requirements for medical devices sold in the EU and EEA countries. CE marking documentation available upon request.
Learn more →Latex-Free
All Rivex products are confirmed latex-free with Certificate of Analysis available for procurement teams and clinicians who need documentation for patient safety protocols.
Learn more →Supply Chain Ethics & UFLPA Compliance
Rivex Medical is fully compliant with the Uyghur Forced Labor Prevention Act (UFLPA). We maintain a hard requirement — not a checkbox — that all cotton-based products be sourced from regions free of forced labor. We require bale-level traceability and certificate of origin documentation for every cotton fiber we source.
Our manufacturing partners in Zhejiang Province source cotton from certified non-restricted origins. We maintain supply chain mapping documentation — including mill-level sourcing records and independent audit reports — available to procurement teams, GPOs, and hospital supply chain managers upon request.
This commitment differentiates us from importers who treat supply chain ethics as a compliance exercise. When you purchase from Rivex Medical, you receive documentation you can present to your own compliance team without qualification.
Ready to get started?
Reach out to discuss your supply needs or request a custom quote for your practice or facility.