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AULEXMED orthopedic support manufacturing workshop in Xiamen

Fabrication de supports orthopédiques · Depuis 2016

Conçu pour des programmes orthopédiques exigeants.

Plus de 4 000 m² de fabrication à Xiamen, 65 modèles et un système qualité documenté pour marque privée, distribution et achats institutionnels.

2016Established
4,000+ m²Approx. manufacturing footprint
15k–23kIndicative units / month
7–10 daysIndicative sample lead time

Architecture produit

Une base industrielle. Un portefeuille orthopédique cohérent.

Lancez une catégorie ou combinez plusieurs modèles compatibles.

01

Short · tall · pneumatic · standard

Walking boots

Protective shell architecture, liner systems, uprights, closures and sizing options for post-injury and post-operative support programs.

52036 · 52002 · 52004 · 52017 · 52006

Walking boots production and quality work at AULEXMED
02

ROM · hinged · stabilizing · immobilizing

Knee bracing

A broad knee platform spanning adjustable range-of-motion structures, rigid stabilization and everyday support formats.

42001 · 42003 · 42007 · 42010 · 42012 · 42019

Knee bracing production and quality work at AULEXMED
03

Ankle · back · shoulder · elbow · wrist

Upper body & soft supports

Sewn and structured supports that extend a program beyond knee and walker categories while sharing materials, packaging and documentation workflows.

52069 · 60241 · 22006 · 22039 · 72020 · 83010

Upper body & soft supports production and quality work at AULEXMED

Capacité industrielle

Un système de production que l’acheteur peut examiner.

Réception, couture, assemblage, contrôle, étiquetage et expédition suivent un flux traçable.

Orthopedic support production floor

Indicative planning capacity of 15,000–23,000 units per month across soft-goods product families.

Final output depends on SKU mix, forecast, automation and production schedule.

Orthopedic product assembly
Finished product packing and shipment preparation
30–45 days

Indicative standard production lead time after final approvals.

500 EA

Common planning MOQ for many standard models; confirmed by SKU.

OEM / ODM

Product selection, brand application, packaging and scoped development.

Qualité et documentation

Des justificatifs organisés en système.

Les copies contrôlées, la correspondance des modèles et le statut actuel sont disponibles pour les projets qualifiés.

Editorial representation of AULEXMED quality and compliance documentation

Representative brand visual. Original documents are not published on this page; controlled copies are available for qualified review.

QMS

ISO 13485:2016

Certificate 117 26 MD 0100 R0 00

Quality-management system certificate stated as valid from 8 June 2026 through 7 June 2029.

US

FDA establishment registration

FY2026 registration 3031170295

Establishment registration and device listings for stated support families. Registration and listing do not mean FDA approval or endorsement.

EU

EU MDR Class I documentation

Applicable product families

Declaration of Conformity documentation is mapped to the relevant model and destination-market scope during project review.

BIO

ISO 10993-23:2021 testing

Report SSMT-R-2025-17620-01B

Skin-irritation test documentation available within the controlled product and material review package.

Document relevance is confirmed by legal entity, product model, material, labeling, intended market and current validity.

Review the quality-document framework →

Exécution du programme

Du cahier des charges à l’approvisionnement régulier.

  1. 01

    Commercial brief

    Target market, channel, product family, forecast and intended cooperation model.

  2. 02

    Model matching

    Existing SKU review, specification comparison and benchmark-sample assessment.

  3. 03

    Sample validation

    Indicative 7–10 business days after model and sample requirements are confirmed.

  4. 04

    Brand & documentation

    Artwork, packaging, labeling, manuals, market documents and quality plan.

  5. 05

    Production release

    Final specification, purchase order, inspection criteria and shipment plan.

  6. 06

    Repeat supply

    Forecast review, product-family planning and corrective-action support when required.

Questions acheteurs

Les informations pratiques, dès le départ.

What is the typical MOQ?

Many standard-model quotations use 500 EA as an initial planning point. Final MOQ depends on SKU, size mix, packaging, branding and material requirements.

How long does production take?

Standard production is typically planned at 30–45 days after the specification, artwork and purchase order are approved. Shipping time is additional.

What can be customized?

Programs may include existing-model selection, logo placement, color direction, retail box, product card, package insert, size guidance and manual content.

Which documents are available?

The controlled review package may include company records, ISO 13485 certification, applicable EU MDR documentation, FDA establishment and listing information, test reports and product-level files.

Démarrer un projet

Présentez un marché, un produit ou un échantillon de référence.

Indiquez catégorie, quantité, marché, personnalisation et documents nécessaires.

You can also email business@aulexmed.com.