What defines a "powerful" silicone medical manufacturer in 2025?
It’s not just production capacity—it’s experience, medical certifications, and precision.Top-tier manufacturers offer ISO 13485 certification, Class 1000 cleanroom facilities, vertical integration, and custom prototyping for complex medical products.
Dive Deeper: Key criteria to evaluate medical silicone suppliers
Certifications and Quality Systems
1.ISO 13485 (Medical Device Quality Management System)
2.FDA registration for exported devices
3.USP Class VI or ISO 10993 biocompatibility compliance
Technical Capabilities
1.Multi-material molding (silicone + plastic, metal, FPC)
2.Liquid and solid silicone molding
3.Micro-molding for catheters, valves, and soft implants
Cleanroom Production：
| Cleanroom Class | Use Case |
| Class 100 | Implant-grade molding |
| Class 1000 | Diagnostic devices |
| Class 10,000 | General medical consumables |
Top manufacturers often operate multiple cleanroom levels, depending on product risk level.
Who are the top customized medical silicone manufacturers in China now?
Here’s a breakdown of key players in 2025.
1. Rising Rubber Technology
Strengths: Large-scale LSR production, automation, catheter systems
Certs: ISO 13485, ISO 9001, FDA registered
Notable Clients: Multinational medtech firms
2. Jiangsu Suconvey Rubber Technology
Strengths: Precision tubing, extrusion + molding, small-batch prototyping
Specialty: Transparent and implant-grade silicones
Edge: In-house material formulation team
3. Siliconeplus
Strengths: Advanced bonding between silicone and plastic/metal/FPC
Certs: ISO 13485, REACH, RoHS
Focus: 3C electronics, wearable medical devices, and soft components
Value: Customized solutions for challenging structural designs
“We help customers go from idea to function with medical-grade silicone that fits complex application needs.”
4. SIMTEC (China Division)
Strengths: German-owned precision LSR molding
Tech: 100% automatic injection systems
Market: High-end diagnostic equipment and valves
5. Dongcheng Medical (Jiangsu Dongcheng Molding)
Strengths: High-volume orthopedic and drug delivery components
Certs: ISO 13485, CFDA approvals
Focus: Domestic hospital procurement + OEMs
How can you choose the right supplier for your medical silicone project?
Knowing your product's complexity helps narrow the field.
For structural parts or bonded assemblies, Siliconeplus excels. For mass-market consumables, Rising Rubber and Dongcheng are better suited.
Dive Deeper: Ask these when sourcing suppliers
Product Requirements
Is the product long-term implantable?
Does it require bonding with plastic, FPC, or metal?
Does it include fine geometries or channels?
Supplier Questions
What medical certifications do you hold?
Can you show proof of biocompatibility for your materials?
Do you offer tool design and validation support?
A truly powerful supplier won’t just answer—they’ll guide you through regulatory challenges, cost control, and DFM (Design for Manufacturing) improvements.
Conclusion
In 2025, top Chinese silicone manufacturers combine medical compliance with custom innovation. Choose based on product complexity and cleanroom needs.
