Medical Silicone Dilator OEM Manufacturer-ISO13485
Need custom dilators for your brand or store? Kenier Co helps brands, buyers, make medical silicone dilators with OEM/ODM support, low MOQ, and private label packaging.Need ISO factory documents, material reports, and testing support?
ISO 13485 and ISO 9001 Factory Support
Our ISO 13485 and ISO 9001 systems help us control materials, production, inspection, and batch records for each order.
Material and Batch Records
We record silicone batches, key parts, production steps, and final inspection results.
Quality Checks Before Bulk Production
We check samples, molds, surface finish, function, packaging, and batch consistency before mass production.
Cleaning and Hygiene-Controlled Packaging
We clean product parts before assembly and use hygiene controls for finished goods and boutique-ready packaging.
Quality Commitment
We keep improving our quality system and use strict controls to keep each OEM order stable, compliance, and consistent.
Lower Sourcing Risk
Clear records and stable quality help reduce returns, complaints, and listing issues.
ISO 13485 Certified
Kenier Co's medical-grade manufacturing processes remain fully certified, ensuring the highest standards of quality and safety for products.
OEM Dilator Solutions for Women Wellness Brands
We make custom vaginal dilators, perineal vibrator products for brands, retailers, and sourcing teams. You can choose size, firmness, color, function, logo, and packaging.
Graduated Dilator Sets
We can make step-by-step dilator sets with smooth tips, soft silicone, and different size levels.
Smooth Designs for Tissue Comfort
We design smooth, ergonomic shapes that help ease tissue discomfort during gradual use and support comfort-focused product lines.
Postpartum and Wellness Product Lines
We support custom dilator sets and related wellness products for postpartum and pelvic care markets.
Pelvic Floor Wellness Products
We can develop vibrating dilators, pelvic floor vibrators, and soft silicone wellness tools based on your product plan.
Progressive Sizes for Menopause Comfort
We offer smooth, progressive size sets that help users gently adapt to vaginal tissue changes during menopause and improve comfort.
Heated and Vibrating Dilator Options
Add vibration, heat, or perineal massage features to fit your product line. We can adjust motor strength, heating range, silicone softness, button design, charging style, and packaging.
Custom Dilator Sets
We make custom dilator sets with progressive sizes, Pantone colors, soft silicone options, vibration, heating, logo, and private label packaging.
We check each custom order from material to final packing. This helps buyers control quality before shipment.
Quality Control for Custom Dilator Orders
Quality Control Process
- Material inspection We check silicone, electronics, color, hardness, smell, and surface finish before production.
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Production Monitoring
We monitor electronics placement, silicone thickness, mixing, injection, curing, demolding, finishing, and bubble control during liquid silicone overmolding. -
Function and Safety Checks
We test vibration modes, charging, buttons, heating, waterproof level, and battery performance based on the product design.
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-Bulk Consistency
We compare bulk goods with the approved sample for size, color, texture, function, and packaging. -
Documents and Testing Support
Available support can include ISO 13485, ISO 9001, CE files, FDA-compliant raw material information, ISO 10993 silicone options, and finished product ISO10993 testing support.
Every Kenier Co vaginal dilator is inspected by experts before shipping, ensuring uncompromising reliability for users and testers.
Sex toy IQC tested lab
Cleaning silicone sleeve
Sex toy UV light box
Constant temperature and humidity chamber lab
OEM/ODM Custom Options
We support custom materials, size sets, firmness, colors, logo, vibration, heating, charging, user manuals, and retail packaging. We also support liquid silicone full overmolding for high-quality vibrators.
Material
Medical silicone, ISO 10993 silicone options, TPE, glass, and 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, or custom Pantone colors.
Pink
White
Brown
Blue
Function
Vibration, heating, perineal massage, app control, memory function, or custom features.
Vibration
Heating
Wireless Remote controlled
App Control
Logo
Silk printed, Laser Carving
Silk Printed
Laser Carving
Packaging Box
Folding box, gift box, display box, shipping box, inserts, and private label packaging.
Folding Box
Gift Box
Display Box
Shipping Box
Why Buyers Work With Kenier Co
ISO 13485 and ISO 9001 Factory
Our ISO 13485 and ISO 9001 factory systems help buyers meet retail channel review needs for department stores, drugstores, and wellness shops, while building trust with consumers and health professionals.
FDA-Compliant Raw Materials and ISO 10993 Options
Our raw materials can meet FDA-related requirements. We also support ISO 10993 silicone materials, and finished products can be tested to ISO 10993 based on your project. Some customer finished products have already passed ISO 10993 testing.
Flexible OEM/ODM for Dilator Sets
We can make custom dilator sets with your size steps, firmness, Pantone colors, logo, and packaging.
Document and Testing Support
We can support CE files, material reports, ISO documents, FDA-compliant raw material information, and ISO 10993 testing documents when your market needs them.
Partner with a Medical-Grade Manufacturer
Kenier Co's certifications ensure pelvic wellness products safely meet strict quality and safety standards while delivering optimal performance for end users. Choose Kenier Co to instantly elevate brand reputation.
What Buyers Should Check Before Ordering
Before placing an OEM order, check the material, silicone feel, motor noise, waterproof level, battery life, packaging, documents, and sample-to-bulk consistency.
Product Quality and Safety
• Odor-Free: Ask for odor control, smooth surface finish, and stable silicone quality.
• Quiet Operation: Check motor noise, vibration strength, and button feel,at least lower 45dB
• 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: Confirm the waterproof level your market needs, such as IPX4 or IPX7.(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:Prepare ISO factory documents, material reports, CE files, packing details, and shipping documents before delivery.
Odor-Free Materials
Quiet Operation <30dB
Durable Motor
IPX7 Waterproof
Build Your Custom Dilator Line With Us
Tell us your target market, order quantity, size set, function, material, and packaging needs. We will suggest a clear OEM plan.
Medical Silicone Dilator - Low MOQ OEM & ODM
We supply custom medical silicone dilators for brands, buyers, and online sellers. We support samples, low MOQ OEM/ODM, private label packaging, ISO factory documents, and testing support.
