Partner with an ISO 13485 certified medical silicone dilator manufacturer
Seeking dilators for FemTech, medical, or wellness clients? Partner with experts who understand therapeutic uses like vaginismus,dyspareunia, and post-surgical rehab. Need full documentation to avoid regulatory risks? As an ISO 13485 certified manufacturer, we build trusted, medically-approved brands.
ISO 13485: From Compliant Manufacturing to Brand Protection
In women's health, brand reputation is vital. Non-certified manufacturers risk recalls, legal issues, and lost trust. Our ISO 13485 certification protects your brand.
Complete Traceability
All raw materials are fully documented and traceable from source to final product, ensuring verified safety.
Rigorous Risk Management
We identify, analyze, and mitigate risks across the product lifecycle to protect users.
Validated Processes
Production, cleaning, and sterilization-ready packaging meet strict medical hygiene standards.
Quality Commitment
Continuous improvement and top-tier controls set us apart from standard factories.
Brand Protection
Partnering with us invests in shielding your brand, customers, and market position.
ISO 13485 Certified
Our medical-grade manufacturing processes are fully certified, ensuring the highest standards of quality and safety for your products.
Key Points and Solution
We design and produce therapeutic dilators for pelvic health conditions, combining manufacturing expertise with clinical insight. Ready to tailor solutions for your specific requirements:
Vaginismus
Creating graduated sets that facilitate gentle, progressive desensitization and muscle control.
Dyspareunia (Painful Intercourse)
Developing smooth, ergonomic designs that help in rehabilitating tissues and rebuilding confidence.
Post-Surgical & Post-Radiation Recovery
Manufacturing devices to help maintain vaginal elasticity post-gynecological, pelvic, or gender-affirming surgeries.
Pelvic Floor Physical Therapy
Collaborating with therapists to produce tools that complement their treatment protocols.
Menopause-Related Atrophy
Providing solutions to gently improve tissue elasticity and comfort.
Hot/Cold Toys + Dilators
Equal to Better Pelvic Health
Pelvic floor dilators fix leaks & tighten muscles. Improving bladder control & sexual satisfaction - ideal for postpartum recovery. Try temperature toys - heat mimics touch, cold boosts sensitivity. Great for new moms & explorers!
Dilator
Supporting customized function, appearance
Quality Control Process for Sex Toy Vibrators
To ensure top performance and safety, our sex toy vibrators undergo strict quality checks at every stage.
Quality Control Process
-
Material Inspection
Only premium materials are used (medical-grade silicone, ABS, TPE, electronics, etc.), tested for durability, safety, and consistency. -
Production Monitoring
Every step—from molding to finishing—is closely monitored for precision and uniformity. -
Rigorous Testing
Functionality Test: Verifies vibration modes, charging, and button operation.
Waterproof Test (IPX4-IPX7):
IPX4: Sprayed from multiple angles for 10 mins.
IPX7: Submerged in 1m water for 30 mins (tested while vibrating).
Post-test drying & recheck to ensure no damage.
Aging & Durability Test:
Continuous Use: Max vibration for hours, checking heat/noise.
Material Test: Exposed to heat, humidity, and UV to prevent degradation.
Sex Toy Testing: Repeated bends, button presses, and port plugging (5,000–10,000 cycles). -
Sample-to-Production Consistency
Each batch is compared to the approved prototype for color, texture, and performance. -
Certifications & Compliance
ISO 9001:2015 – Ensures standardized quality management.
CE Certified – Guarantees EU safety compliance.
Every sex toy vibrator is inspected by experts before shipping, ensuring reliability for users and sex toy testers.
Sex toy IQC tested lab
Cleaning silicone sleeve
Sex toy UV light box
Constant temperature and humidity chamber lab
Your Customization Optional
Customized adult products with premium silicone (colors/firmness), TPE or ABS. Add logos, USB/magnetic charging, vibration modes & branded packaging. We offer complete ODM/OEM solutions to meet your specific requirements.
Material
Medical grade silicone, TPE, glass, stainless steel
Medical Silicone
TPE
TPR
Stainless Steel
Charging
Battery, Button battery, DC 5V charging, Magnetic charging
Battery
Button Battery
DC 5V Charging
Magnetic Charging
Color
Pink, white, black, any color you are interested in, share spot color or pantone color
Pink
White
Brown
Blue
Function
Standard vibration, heating, rotation, suction, app control, memory function, or custom features as required.
Vibration
Heating
Wireless Remote controlled
App Control
Logo
Silk printed, Laser Carving
Silk Printed
Laser Carving
Packing Box
Simple folding packing box, Shipping packing box, Gift Box, Display box, box inserts
Folding Box
Gift Box
Display Box
Shipping Box
Our Advantage
ISO 13485 & FDA Certified
Ensure your products meet global medical standards for seamless market access and instant credibility with professionals and consumers.
100% Biocompatible Medical-Grade Silicone
We use platinum-cured silicone, rigorously tested for biocompatibility. Non-toxic, odorless, and body-safe—eliminating irritation risks for sensitive users.
Flexible OEM/ODM for Dilator Sets
Our team develops dilator sets with progressive sizing, custom durometry, colors, and branding to match your therapeutic goals and market strategy.
Regulatory & Certification Support
Leverage our expertise to secure certifications (CE, local) under your brand. We provide full documentation and accelerate your market entry.
Partner with a Medical-Grade Manufacturer
Our certifications and quality standards ensure your products not only meet regulatory requirements but also provide the highest level of safety and efficacy for end users. Choose a partner that elevates your brand's reputation.
Top Factors When Sourcing Silicone Dilator
Sex products buyers must evaluate suppliers on quality, safety, and compliance to avoid risks.
Product Quality & Safety
• Odor-Free: Triple deodorizing process (acid wash, ozone, vacuum).
• Quiet Operation: Under 30dB for discreet use.
• Durable Motor: High-precision or Japanese NMB motor (with QC reports).
• Battery Life: 1-hour runtime per charge; 300+ charge cycles (retains 80% capacity); Low-quality batteries (<200 cycles) fail QC
• Waterproof Rating: IPX4-7 (splash-proof, bathtub Waterproof).
• Simple Vibration Modes: 4-5 patterns (avoid overwhelming choices).
• Screen Memory Function (if applicable) for easy preference recall.
• EU Market Risk: Non-CE USB models may face customs seizures.
• Smooth Shipping: Professional documentation (FDA, CE, material certificates) to avoid inspection delays.
Odor-Free Materials
Quiet Operation <30dB
Durable Motor
IPX7 Waterproof
Elevate Your Brand with a Medically-Certified Manufacturing Partner.
Let's discuss how our certified processes and deep product expertise can become your greatest competitive advantage.
Silicone Dilator - Low MOQ OEM & ODM
Vaginal dilator supplier, we offer end-to-end solutions from design to delivery. Specializing in small-batch production and custom OEM/ODM services, we help brands and retailers create unique, market-ready products.
