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Our certificate

 

Possess 800 square meters of Class 10,000 dust-free workshop, Passed ISO9001:2015 quality management system certification and ISO13485:2016 medical device quality management system, and its products have obtained multiple biocompatibility tests, US FDA and EU LFGB certifications.

Class 10,000 cleanroom certification
Class 10,000 cleanroom certification
ISO 9001:2015
ISO 9001:2015
ISO 13485:2016
ISO 13485:2016
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Tail vein injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Intraperitoneal injection
ISO 10993－11:2017 Pyrogens
ISO 10993－11:2017 Pyrogens
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for extract of 0.9% sodium chloride injection
Skin irritation test for sesame oil extraction
Skin irritation test for sesame oil extraction
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs using the maximization method with 0.9% sodium chloride injec
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Skin sensitization test in guinea pigs:maximization method with sesame oil extraction
Cell toxicity test:agar diffusion method
Cell toxicity test:agar diffusion method

Cooperating customers

 

Till now, Exnan products has been exports 35 countries, and more than 500 Medical equipment factory, health care companies, hospitals, clinics use our products, and win good reputation.

osi
Philip
woodpecker
Zoll
奥美医疗
戴维医疗
股份研祥智能
国赛
劲拓股份
乐普
日东科技
稳健医疗
燕麦科技
源兴基因
medtronic
nonin
振德医疗
林华
超思
安得医疗

New

 

Our silicone accessories meet international medical standards through strict quality control.

Ensure patient safety with our premium products. Explore our catalog today!

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News

 

Our silicone accessories meet international medical standards through strict quality control.

Ensure patient safety with our premium products. Explore our catalog today!

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Recent News

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19 2026/05

top Reco Medical Silicone Mold Design: The First Gateway to Product Precision

The precision and quality of medical silicone components heavily depend on mold design. LSR molding imposes special requirements for cold runners, precision venting, uniform temperature control, and demolding structures. Needle-valve cold runners reduce waste; venting grooves and vacuum assistance prevent trapped air; multi-zone temperature control ensures consistent curing; and proper ejectors or sliders avoid tearing. Stainless steel molds with anti-stick coatings extend life. High-precision m

custom medical silicone components

18 2026/05

top Reco New Requirements of ISO13485:2016 for Medical Silicone Suppliers

The upgrade to ISO13485:2016 imposes higher requirements on medical silicone suppliers: risk management, process validation, full traceability, and clean environment control. Biocompatibility reports (e.g., ISO10993) are required for materials, and production parameters must be documented. Suppliers need a controlled documentation system and must accept customer audits. Companies with independent cleanrooms, precision testing equipment, and training systems gain competitive advantages. Guangdong
14 2026/05

top Reco Medical Silicone Consumables Market Sees New Growth: Respiratory Equipment Drives Demand for Precision Components

Growing demand for respiratory medical devices is driving rapid expansion of the medical silicone consumables market. Silicone is the preferred material for masks, seals, and other components due to its biocompatibility, sterilization resistance, and softness. The global medical silicone market is expected to exceed USD 10 billion by 2027, with Asia-Pacific leveraging manufacturing advantages. Medical-grade products require strict control over cleanliness, precision, and batch consistency. Leadi
12 2026/05

top Reco From Concept to Compliant Mass Production – EXNAN’s One‑Stop Custom Implantable Silicone Components Service

EXNAN provides one‑stop custom silicone component services for short‑term (≤29 days), medium‑term (29–365 days), and long‑term (>365 days) implantable devices. We manage the entire workflow: design, material selection, tooling, process validation, volume production, sterilization, and packaging. For each implant duration, we optimize aging resistance, low leachables, easy removal, or permanent stability accordingly. Production takes place in a Class 10,000 cleanroom under ISO 13485 with full

custom medical silicone components

09 2026/05

top Reco LSR Liquid Silicone Rubber – Driving the Precision Manufacturing Transformation in Medical Components

LSR (Liquid Silicone Rubber) is transforming medical component manufacturing. Growing at 10.07% CAGR, the LSR market reached $3.71B in 2025 and accelerates as device miniaturization demands high-precision, flash-free parts. LSR injection molding enables automated cycles of seconds, ideal for multi-lumen manifolds, thin-wall seals, and drug delivery systems. Recent launches: DuPont Liveo™ C6-8XX (USP Class VI, EtO/gamma compatible) and Momentive Silopren™ LSR 4000 (micro-molding optimized). With

custom medical silicone components

30 2026/04

top Reco Without Post-Curing, Would You Use This Silicone Part in a Medical Device?

Post-curing is an essential step in medical silicone manufacturing that cannot be skipped. Without it, residual unreacted substances and low-molecular-weight cyclics can cause leachable contamination, cytotoxicity failure, performance drift, and odor. Buyers should verify post-curing by reviewing batch records, smell testing, requesting data, and on-site audits. Post-curing is a fundamental requirement for medical-grade quality.

custom medical silicone components

27 2026/04

top Reco EXNAN: The Precision Silicone Partner Trusted by Implantable Device Manufacturers

The global implantable silicone components market is expanding rapidly. Manufacturers require suppliers with proven quality systems, biocompatibility certification, and precise manufacturing capabilities. EXNAN has become a preferred partner for implantable silicone part producers, offering custom OEM solutions for critical applications such as implantable port sealing plugs and base assemblies. With over 20 years of engineering experience, a 10+ year production quality team, and in-house testin

custom medical silicone components

23 2026/04

top Reco Why Customization Is the Future of Medical Silicone Components – And Why Off-the-Shelf Parts Are Losing Ground

Off-the-shelf silicone parts hide risks in performance, compliance, and total cost. Medical devices need precision – not “almost.” Custom-engineered components fit your design exactly, ensure full biocompatibility documentation (ISO 10993, FDA MAF), and reduce assembly defects. Customization turns a simple part into a strategic asset. For medical device manufacturers, it is no longer a luxury – it is a necessity.

22 2026/04

top Reco 5 Core Properties of Medical-Grade Silicone: Why It’s the Preferred Material for Medical Devices

As the preferred material for medical devices, medical-grade silicone features excellent biocompatibility, sterilization resistance, high elasticity and precision customization capability, complying with strict standards such as USP Class VI and ISO 10993. We specialize in high-end custom medical silicone components, produced via platinum-cured process and ISO 13485 system, providing safe, compliant and high-precision silicone solutions for minimally invasive devices and respiratory equipment.

Welcome to contact us

If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company

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    Welcome to contact us

    If you have any questions, please fill in the relevant information. Weare very willing to provide more information and a full range ofservices for both you and your company

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    EXNAN 

    Copyright © 2004-2024 Guangdong Exnan Technology Co.,Ltd

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    Copyright © 2004-2024 Guangdong Exnan Technology Co.,Ltd

      sales01@exnan.com

      +86-0752-3869959 / 3869960

      +86 180 0752 8206

      Building 8, China-Korea Emerging Intelligent Manufacturing Industrial Park, No.27, Songbailing Road, China-Korea (Huizhou) Industrial Park, Zhongkai Area, Huizhou City, Guangdong Province, China

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