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HUIMAIN HIFU CE & FDA Registration Service

HUIMAIN provides professional HIFU CE and FDA registration services for beauty and medical device makers. We offer document preparation, testing coordination, clinical support, and quality system guidance to help streamline approvals.
Model
4-in-1 Cryo HIFU Machine
Product Name
4-in-1 Cryo HIFU Machine
Structure
Desktop integrated HIFU system with four functional handpieces
Cooling System
Intelligent cryo-cooling (HIFU cooling + ice hammer cooling)
Voltage
AC 220–240V 50/60 Hz
Applicable Clients
Beauty salons, SPA centers, distributors, non-medical clinics
Treatment Areas
Face, neck, jawline, eye area, abdomen, arms, thighs
Laser Type
N/A (High-Intensity Focused Ultrasound)
Handles
Face HIFU handle, body HIFU handle, eye HIFU handle, optional multi-line HIFU
Technology Type
High-Intensity Focused Ultrasound (HIFU)
Screen
Smart UI system with treatment counter + energy calibration
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Product Details

Professional HIFU CE & FDA Registration Service by HUIMAIN

HUIMAIN offers a clear, reliable HIFU CE and FDA registration service tailored for beauty and medical device manufacturers. Backed by a strong R&D team, experienced engineers, and a clinical test department, we help clients prepare complete technical files, arrange testing, and navigate regulatory processes with confidence.

What We Offer

Regulatory Assessment

We start with a full review of your HIFU device to determine the correct classification and the path for CE marking (MDR/IVDR where applicable) or FDA clearance/510(k). This step reduces surprises and sets a realistic timeline.

Documentation & Technical File

Our team prepares or reviews the technical file, risk analysis (ISO 14971), clinical evaluation reports, labeling, and instructions for use. We ensure documents meet EU and US requirements for submission.

Testing & Clinical Support

HUIMAIN coordinates required safety and performance testing (electrical safety, EMC, performance verification) and supports clinical data collection when needed. We work with accredited labs and our internal clinical test experts to ensure quality results.

Quality System Guidance

We advise on ISO 13485 implementation and documentation needed for regulatory review. A solid QMS shortens review time and supports long-term market success.

Why Choose HUIMAIN

With a 3,000 m² facility, strong technical staff, CE and SGS approvals, and multiple patents, HUIMAIN combines product knowledge with regulatory expertise. We specialize in OEM/ODM for beauty machines and have global market experience in Asia, the Middle East, Europe, and North America.

Simple, Transparent Process

Our service is step-by-step and client-focused: assessment, documentation, testing coordination, submission support, and post-market advice. We communicate clearly, set realistic timelines, and provide regular updates. While we guide and prepare the strongest possible application, final approvals rest with regulatory authorities.

Contact HUIMAIN today to streamline your HIFU CE and FDA registration process and bring your device to market with confidence.

Detailed display

  • 4-in-1 Cryo HIFU device for skin tightening and facial treatments.
  • 4-in-1 Cryo HIFU cartridges of different sizes.
  • Different cartridges of 4-in-1 Cryo HIFU machine.

Certificate display

  • Medical-device-production-license

    Medical-device-production-license

  • RoSH

    RoHS

  • Medical-device-business-license

    Medical-device-business-license

Question you may concern

What is an EMS Body Sculpting Machine?

An EMS Body Sculpting Machine is a non-invasive device that uses High-Intensity Electromagnetic (HIEMT) or Electrical Muscle Stimulation (EMS) technology to stimulate muscle contractions and promote fat reduction. It helps tighten, tone, and strengthen muscles in targeted areas such as the abdomen, buttocks, thighs, and arms.

Is this device suitable for everyone?

The device is suitable for most people but is not recommended for pregnant women or individuals with heart conditions. Please consult a professional before use.

How long does a treatment session take?

Treatment sessions typically last 30-60 minutes depending on the area being treated.

What body areas can be treated?

It can be applied to the abdomen, thighs, arms, buttocks, and legs for fat reduction and muscle toning.

If you have any questions about our goods or services, please feel free to contact us.

Let's talk
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Guangzhou Huimain Technology Co., Ltd.
Room 307, Building A, Huilong International E-commerce Industrial Park, No. 10 Xipengling Road, Helong Street, Baiyun District, Guangzhou, China
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Tags
compare HIFU machines
compare HIFU machines
Skin Tightening
Skin Tightening
HIFU skin tightening machine
HIFU skin tightening machine
Hair Remover
Hair Remover
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