Rivex Medical

Compliance Center · Updated quarterly

Audit-ready by default.

Procurement teams need the paperwork. Since 1978, we've kept it organized and current. Every document in this archive is available to institutional buyers — typically within one business day of request.

PDF

FDA Establishment Registration

Rivex Medical is registered with the FDA as an importer-distributor of Class I medical devices. Renewed annually, registration number available on request under NDA.

Request →PDF

ISO 13485:2016 Sourcing Certificates

All manufacturing partners hold an active ISO 13485:2016 certificate. We re-verify each certificate at renewal and audit annually.

Request →PDF

Latex-Free Certificate of Analysis

Every Rivex SKU is manufactured in latex-free production lines. Per-lot CoA available with each shipment to institutional accounts.

Request →PDF

UFLPA Cotton Sourcing Statement

All cotton-content products ship with full chain-of-custody documentation demonstrating non-Xinjiang origin. UFLPA compliant.

Request →PDF

GS1 US Membership & GTIN Assignment

Rivex assigns a unique GS1 GTIN to every SKU, scanned at warehouse intake and printed on every shipping label.

Request →ZIP

Material Safety Data Sheets

MSDS for every SKU updated to OSHA HCS 2012 / GHS standard. Multilingual versions available on request.

Request →PDF

Quality System Manual

Rivex internal QMS aligned to ISO 13485 principles. Available to qualified institutional buyers under NDA.

Request →PDF

Returns, Recalls & Corrective Action

Process for product returns, lot recall, and corrective action — including the 60-day return window and lot-level traceability.

Request →

Need something not on this list?

We maintain dozens of additional internal documents — supplier audits, transit-temperature logs, pallet-level lot manifests. Email [email protected] with the document name and your account.