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Operators assembling silicone electronic products on Leutoo's cleanroom assembly line in Dongguan

Fig. 01 — Final assembly line, Floor 6, Dongguan

OEM & ODM silicone manufacturer · Est. 2016

Liquid silicone, engineered for mother & baby brands.

We design, mold and assemble lactation massagers, baby nail trimmers, pacifiers and pelvic floor trainers for brands in the US and Europe. It all happens under one roof in an ISO 13485-certified LSR factory, from your first sketch to cartons on the dock.

  • Liquid silicone injection molding
  • Full encapsulation · IP67
  • Heat · Cool · Vibration modules
  • Shore 0–50A
  • ≤ 45 dB motor noise
  • Pantone color matching
  • NNN-protected development
  • ISO 13485 · ISO 9001
  • 2016

    Founded in Dongguan

  • 9,000m²

    Production floor, 3 levels

  • 200+

    People on site

  • 5M

    Units per year capacity

  • 20+

    Dedicated QC inspectors

  • 10+

    R&D and tooling engineers

01 / What we build

Mother & baby care

Four product lines. One silicone platform.

Every product here starts as liquid silicone rubber on our own presses. We tool it, mold it, fit the electronics and test it in house. Bring a finished design, or start from one of our platforms and make it yours.

  • 01 Fig. 01
    Purple silicone lactation massager with a polished metal heat-and-cool tip and a textured vibration pad

    Lactation massagers

    Warm, cool and vibrate in one fully sealed LSR body. Heat and cold-compress modules (cooling below 5 °C), multi-mode vibration, a rechargeable pack and IP67 waterproofing. Our ISO 13485 certificate covers manufacture of medical breast massagers.

    Heat + coolVibrationIP67ISO 13485 scope
  • 02 Fig. 02
    Sage-green electric baby nail trimmer with three interchangeable color-coded filing pads

    Baby nail trimmers

    Quiet, low-speed electric trimmers with soft-touch silicone bodies and swappable pads from newborn to toddler. Designed around small fingers, tired parents and babies who are asleep.

    Low-noise motorSoft-touch LSRSwappable pads
  • 03 Fig. 03
    Sage-green silicone pacifier with a ventilated shield, handle ring and clear orthodontic LSR teat

    Silicone pacifiers

    One-piece LSR nipples and shields molded without seams where residue can collect. Orthodontic or cherry shapes, custom shields and Pantone colors. We build to your target standard and arrange testing at the lab you choose.

    One-piece LSROrthodontic / cherryPantone match
  • 04 Fig. 04
    Blush-pink silicone pelvic floor trainer with a curved control tail and magnetic charging contacts

    Pelvic floor trainers

    Kegel balls and smart pelvic floor trainers for postpartum recovery. Weighted or vibrating cores are fully encapsulated in body-safe liquid silicone, with smooth, pore-free surfaces that are easy to clean.

    Weighted / vibratingFull encapsulationIP67

Need something else in silicone? We also mold custom LSR parts to your drawings. See LSR capability →

02 / Core process

Liquid silicone rubber

LSR injection molding, sealed around the electronics.

Liquid silicone flows around the circuit board, motor and heater, then cures into one continuous, seamless skin. There are no glue lines to split, nothing to trap moisture, and the surface feels soft against skin. That's why we build products that touch mothers and babies this way.

4 vertical LSR injection molding machines on Leutoo's molding floor in Dongguan
Fig. 02 — 4 vertical LSR injection presses, up to 200 t
Operator soldering motor leads on a semi-automatic soldering machine before silicone encapsulation
Fig. 03 — Motor leads soldered before encapsulation

Spec sheetLTO-LSR-01

Process
Liquid silicone injection molding (LSR), plus compression molding for low-volume parts
Encapsulation
Full liquid encapsulation of PCB, motor, heating element and battery, or semi-encapsulated shells
Hardness
Shore 0–50A, soft-skin to structural
Ingress
IP67 waterproof sealing, checked with in-line waterproof testing
Acoustics
Motor noise ≤ 45 dB
Finish
Matte, silky oil-spray coating, polished or textured; laser marking
Color
Pantone-matched, with color-fastness tested
Tooling
In-house mold design and prototyping; exclusive tooling ownership available
Explore our LSR injection molding capability

03 / OEM · ODM process

6 stages, one factory

From brief to boxed product, without handing off.

OEM, hybrid or full ODM: compare your options
  1. 01

    Brief & NNN

    We sign your NNN (non-disclosure, non-use, non-circumvention) agreement before any drawings change hands. Then we review the target market, price point, certifications and volumes with you.

    Output Feasibility + budget quote

  2. 02

    ID & structure

    Our engineers work out the industrial design, wall thicknesses, sealing and PCB layout for LSR, so the part molds cleanly and survives drop and water tests.

    Output 3D data + DFM report

  3. 03

    Tooling & T1 samples

    Molds are designed and cut, then first-shot samples come off the press with your Pantone color and texture for you to check.

    Output T1 samples + mold report

  4. 04

    Validation

    Reliability testing runs in our lab: button life, cable flex, drop, salt spray, temperature and humidity. Third-party certification testing goes to the lab you choose.

    Output Test reports + golden sample

  5. 05

    Mass production

    Molding, spraying, assembly and charging run under ISO 9001 and ISO 13485 controls, with IQC, in-process and final inspection at every stage.

    Output Lot records + QC data

  6. 06

    Pack & ship

    Retail boxes, inserts and manuals are made to your brand. Cartons are drop- and transport-tested, labeled for Amazon FBA or your 3PL, and shipped from Dongguan.

    Output Shipping docs + photos

04 / Quality system

Certified · Audited · Tested

Certificates you can download. Tests you can watch.

More than 20 quality staff run IQC, PQC, FQC and OQC at every stage. The reliability lab next to the lines tests new designs before tooling is signed off, and tests production lots before they ship.

ISO 13485:2016 certificate issued to Dongguan Leutoo Silicon Electronics Co., Ltd.

Medical device quality management

ISO 13485:2016

Scope
Manufacture of medical breast massagers
Issuer
SGS United Kingdom Ltd (UKAS accredited)
Cert no.
CN25/00005740
Valid until
21 Aug 2028
Download PDF
ISO 9001:2015 certificate issued to Dongguan Leutoo Silicon Electronics Co., Ltd.

Quality management system

ISO 9001:2015

Scope
R&D and production of silicone electronic massagers, incl. mother & baby products
Issuer
Shanghai Sailway Certification (CNAS accredited)
Cert no.
SW25Q21479R0M
Valid until
13 Nov 2028
Download PDF

Social compliance

amfori BSCI

Full social audit by SGS in September 2025.

Audit summary: available upon request

Request the summary
Key-life and horizontal insertion-force test machines in Leutoo's reliability lab
Fig. 04 — Key-life and insertion-force testers

In-house reliability lab08 tests

  1. T01

    Plug & unplug

    Charging-port insertion cycles and connector retention

  2. T02

    Button life

    Automated key-press endurance on every switch design

  3. T03

    Swing life

    Cable and joint flex until the design proves its fatigue limit

  4. T04

    Motor inspection

    Speed, current and noise checked on incoming motors

  5. T05

    Salt spray

    Corrosion resistance of contacts and metal parts

  6. T06

    Temp & humidity

    Climatic chamber cycling for storage and use conditions

  7. T07

    Drop test

    Product and retail pack dropped from set heights

  8. T08

    Transport test

    Vibration-table simulation of export freight

Full quality system & certificates

05 / Track record

Trusted by brands selling across the US, Europe and Asia.

We protect our clients the way we protect your design: their names stay private unless they choose otherwise. References are available to serious buyers under NDA.

  • US · EU · UKMarkets our clients sell into
  • Amazon & retailWhere our products are sold
  • Mother & babyPlus wellness and medical brands
  • Under NDAClient names shared with qualified buyers

06 / The factory

Building 17, Yungu Industrial Park, Changping

Three floors, one production chain.

Molding, spraying and polishing are on Floor 7. Laser marking and assembly are on Floor 6. Packing and the warehouse are on Floor 5. Visit in person, or book a live video walk-through of the lines before you place a sample order.

About Leutoo & the factory
Long cleanroom assembly benches with fume extraction at Leutoo, Dongguan
Assembly · Floor 6
Inspection line with operators in cleanroom gowns
Inspection line
Finished-goods warehouse with palletized export cartons
Finished-goods warehouse
Reception lobby of Dongguan Leutoo Silicon Electronics
Reception
Customer meeting room used for design reviews and audits
Design reviews & audits

07 / Buyer questions

Straight answers before you ask.

Can't find what you need? Email elvis@leutoo.com and an engineer will reply within one working day.

Q01 What is your minimum order quantity (MOQ)?

Our minimum order quantity is 2,000 pcs. That applies to private-label orders on our existing platforms and to custom ODM products with new tooling.

Q02 Who owns the molds and the design?

On custom projects, you can own the tooling and the product IP outright. We sign an NNN agreement (non-disclosure, non-use, non-circumvention) before we receive your drawings, and we never sell your design to other buyers.

Q03 What are your lead times?

New tooling takes 25–30 business days, after which T1 samples come off the press for your approval. Private-label orders on our existing platforms take about 25 business days. Stock samples ship in about a week.

Q04 Can you help with certifications such as CE, FCC or FDA registration?

Yes. We design for your target market from day one, supply the technical files and samples, and work with the accredited lab you choose. Our ISO 13485 system covers the manufacture of medical breast massagers, which supports medical-device registrations.

Q05 Do you provide samples before an order?

Yes. Stock samples of our existing platforms can ship within about a week. For custom projects, T1 samples come straight off the production tool, so you approve exactly what will be mass-produced.

Q06 Can we audit the factory?

Yes. Buyers and third-party inspectors are welcome on site in Changping, Dongguan, about an hour from Shenzhen and Guangzhou. We also offer live video tours of the lines.

08 / Request for quotation

Tell us what you're building.

An engineer, not a sales script, replies within one working day with questions, a feasibility view and next steps. Tick the NNN box and we'll send our signed NNN agreement before you share drawings.

Replies within 1 working day · GMT+8