2016
Established
10,000+
Sq Meters Facility
200+
Employees
110M
2024 Sales Volume
ISO Certified Excellence
ISO9001, ISO13485, ISO14001, SA8000, BSCI certified operations
100% Test Pass Rate
Guaranteed quality with comprehensive testing procedures
OEM and ODM
From concept to mass production, serving USA, EU and global markets
Liquid Injection Molding
Advanced LSR technology for premium silicone products
Trusted Silicone Manufacturing Partner Since 2015
Our Mission
Dongguan Leutoo Silicon Electronics Co., Ltd. is a professional OEM & ODM silicone product manufacturer specializing in adult wellness products, medical silicone devices, and mother & baby care products.
With over 10,000㎡ of factory space, advanced liquid silicone injection molding (LSR) technology, and a full in-house testing laboratory, we support global brands from product concept → mold development → mass production → compliance testing.
Our customers include brand owners, Amazon sellers, distributors, and medical device companies primarily in the United States and Europe.
Our Growth Journey
Company Established
sales: 12m
2016
expanded operations
sales: 30m
2018
global partnerships
sales: 70m
2020
advanced technology
sales: 110m
2024
A few things we’re great at
OEM & ODM Manufacturing Services Built for Global Brands
We help you go from idea → finished product with speed, confidentiality, and compliance.
OEM (Private Label Manufacturing)
Custom product branding
Pantone color matching
Package & retail box development
Low MOQ for brand testing
Scalable mass production
ODM (Product Design & Development)
Structural & industrial design
Mold design & prototyping
Functional testing & revisions
Full IP-protected development
Exclusive tooling ownership
Medical-Grade Silicone Device Manufacturing (ISO 13485)
Leutoo operates under a strict ISO 13485 medical quality system, ensuring:
Batch traceability
Risk management control
Documented production validation
Medical-grade raw materials
Biocompatibility-ready processes
We manufacture:
Pelvic floor therapy devices
Physical rehabilitation accessories
Medical-grade silicone tools
Patient-safe contact products
Designed for USA regulatory pathways and distributor compliance.
Liquid Silicone Injection Molding (LSR)
Our advanced LSR injection molding capabilities represent the cornerstone of our manufacturing excellence.
Utilizing state-of-the-art equipment and proprietary process controls, we achieve unprecedented precision and consistency.
pricision control
Automated dosing systems ensure consistent material properties;
Ultra-soft skin-safe textures
Waterproof sealing (IPX7 capable)
Precise internal structures
Medical-grade tolerance control
Long-cycle durability
ideal for
Medical devices
Adult wellness devices
Baby care products
Waterproof electronics enclosures
clean room environment
Contamination-free manufacturing for medical applications
real time monitoring
Continous process monitoring with stastical process control
Quality control measures
We perform 100% QC inspection on critical components and support third-party lab testing when required.
Advance Manufacturing Capabilities
State-of-the-art liquid silicone injection molding with precision control systems and
clean room environments.
Production Capacity
Scalable infrastructure for projects from prototypes to high-volume production
Quality Testing
Comprehensive testing including durometer, tensile strength, and biocompatibility
Rapid Prototyping
Quick turnaround for design validation and testing with advanced tooling
Production Process Flow
LIQUID INJECTION
ASSEMBLY
MOLDING
INSPECTION
POLISH
GRINDING
CLEANSING
OIL COATING
CHARGING
PACKAGING
WAREHOUSING
Reliability Testing Procedures
plug & unplug test
Connector reliablity testing
Button life test
Switch edurance validation
swing life test
Mechanical movement testing
motor inspection
Motor performance validation
salt spray test
Corrosion resistance testing
climate control
Temperature & humidity testing
drop test
Impact resistance validation
transportation test
Shipping durability test
Quality & Certifications
Comprehensive quality management systems ensuring compliance with international standards and regulatory requirements.
Our commitment to quality excellence is demonstrated through our comprehensive ISO certification portfolio,
representing adherence to the highest international standards across multiple disciplines.
ISO Management System Certifications
ISO
9001
qUALITY MANAGEMENT SYSTEMS
ISO
13485
MEDICAL DEVICE QUALITY MANAGEMENT
ISO
14001
ENVIRONMENTAL MANAGEMENT SYSTEMS
SA
8000
SOCIAL ACCOUNTABILITY STANDARD
BSCI
BUSINESS SOCIAL COMPLIANCE
Product Compliance Certifications
CE
EUROPEAN CONFORMITY
UKCA
UK CONFORMITY ASSESSED
UL
UNDERWRITERS LABORATORIES
FDA
FOOD AND DRUG ADMINISTRATION
REACH
REGISTERATION,
EVALUATION,
AUTHORIZATION
PRO65
CALIFORNIA PROPOSITION 65
FCC
FEDERAL COMMUNICATIONS COMMISION
RoHS
Restriction of Hazardous Substances
Our manufacturing process is designed to satisfy
U.S Customs
Amazon Compliance
EU Import Regulations
Medical Distributor Audits
Innovation & Intellectual Property
Continuous innovation driving product development and market leadership
MULTIPLE PATENT
Applied for multiple invention patents protecting our innovative technologies
R&d INVESTMENT
Continuous investment in research and development for cutting-edge solutions
fUTURE INNOVATIONS
Expanding into big health series and advanced LSR technologies
Why Work With Our Factory?
Balanced OEM + medical manufacturing expertise
Stable raw material supply chains
Strict NG rate control
Confidential IP protection
Transparent cost structure
On-time delivery
Engineering-driven production support
we co-engineer your product for profitability and market success.
Partners & Clients
Trusted partnerships with leading international brands, delivering excellence across global markets.
Office Culture
Our Product Portfolio
Comprehensive range of silicone electronic products designed for health, wellness, and specialized applications.
Adult Products
Liquid fully encapsulated silicone products with IP67 waterproof rating and ultra-quiet operation ≤45dB.
Mother & Baby Care
Silent breast pumps and thermal therapy products designed for maternal and infant wellness.
Health Services
Advanced heating technology with infrared penetration 10x deeper than conventional methods.
Sm Products
Premium leather and PU products with precision hardware, salt spray tested for 48+ hours.
Premium Baby Care Products
Our maternal and infant care products are designed with the highest safety standards, featuring medical-grade silicone construction and innovative designs that prioritize both functionality and comfort.
Start Your OEM or Medical Device Project Today
Whether you’re launching a new brand or expanding an existing medical product line, our engineering and compliance team is ready to support you.
✅ NNN protection (Non-Disclosure, Non-Use, Non-Circumvention agreement)
✅ Commercial feasibility analysis
✅ Mold cost forecasting
✅ Production timeline planning
Contact & Inquiry
Ready to partner with us? Get in touch for quotes, samples, and technical specifications.
Request Quote & Information
Get in touch
Building 17, Yungu Industrial Park
No. 136 Gangjian Road, Changping Town
Guangdong Province, China
Monday – Friday 8:00 AM – 6:00 PM
Saturday: 9:00 AM – 5:00 PM
Sunday: Closed
Leutoo
Leading innovation in silicone electronics manufacturing since 2016
ISO 9001 | ISO 13485 | ISO 14001 Certified
Products
Health Series
Maternal & Baby Care
Adult Products
SM Series
Services
Custom Manufacturing
Product Development
Quality Testing
Technical Support
Company
About Us
Certifications
Contact
Partnership