Manufacture your medical brand in Mexico
Laboratorios Le Roy manufactures private-label and OEM wound care, elastic bandages, orthopedic supports and disposables for distributors and brand owners — to the standards of a manufacturer that has made medical devices since 1937.
A heritage manufacturer, factory-direct
An OEM programme with Le Roy means a manufacturer with nearly nine decades of experience, an ISO 13485 / ISO 9001 quality system and a brand trusted across Latin America — not a trading intermediary. You get stable quality, documented compliance and factory-direct pricing.
Mexican origin gives buyers serving the United States and Canada a USMCA duty advantage over Asian sourcing, with shorter transit to the Americas and US-based support through Ambra Le Roy.
From specification to first container
A clear route takes your programme from brief to shipment.
Brief & target
Lines, references, price tier, certification and market — mapped to our plant.
Spec & sample
Material, dimensions, compression and packaging fixed in a specification, with samples.
Artwork & packaging
Boxes, sleeves and bags printed to your design, regulatory text checked per market.
Registration support
ISO 13485, ISO 9001, GMP and lot documentation for your import registration.
Production & QC
Scheduled runs with in-line QC and a certificate of analysis per lot.
Logistics
EXW, FOB, CFR or CIF from Mexico, with export documentation for your market.
Documentation that clears customs
Manufacturing runs under ISO 13485 and ISO 9001 with COFEPRIS Good Manufacturing Practices and product health registrations, with per-lot certificates of analysis.
We provide the documentation package importers need for national registration and customs clearance — ask for the current certificate set for your market.
Frequently asked questions
What is the minimum order for private label?
Typically one full container per programme; mixed-line containers can bridge first orders across wound care, bandages and supports.
Can you match an existing product?
Yes — send a target sample or specification and we match material, dimensions and packaging, documented in pre-production samples.
Who owns the brand and artwork?
You do. Specifications and artwork developed for your brand stay confidential to your programme.
Do you help with import registration?
We supply the ISO 13485, ISO 9001, GMP and lot documentation your authority requires; the registration is filed by you or your local agent.
Start a private-label programme
Send your brief — lines, market and volumes — and get a feasibility answer with indicative pricing within days.