BUTTER-C
Medical devices
Ultrasound gel OEM/ODM manufacturing
Ultrasound Gel · Ultrasound Transmission Gel · OEM/ODM
Ultrasound gel is the coupling medium placed between the probe and the skin, removing the layer of air so ultrasound waves travel efficiently and the image is clear. Clinics and hospitals use large volumes of gel every day, so they need consistency from batch to batch: clear, bubble-free, with a medium viscosity that stays in place yet glides smoothly, non-greasy, easy to wipe off and not damaging to the probe. Please note: ultrasound gel is a medical device and does not belong to the cosmetic category — its classification, registration dossier and manufacturing requirements follow the separate regulations for medical devices. Butter-C advises on the formula and packaging; the manufacturing approach and documentation are discussed separately for each project.
Formula base
Clear, bubble-free aqueous gel
Ultrasound gel is a simple aqueous gel; its quality lies in clarity, viscosity and the removal of air bubbles.
Gelling agents
Neutralized carbomer or cellulose derivatives — a clear gel with stable viscosity.
Humectants
Propylene glycol, glycerin — keep the gel from drying out quickly during the procedure.
Preservation
A preservative system suited to large containers that are opened many times.
Color
Colorless or light blue for easy identification.
Key technical points
Four factors that determine the quality of an ultrasound gel
Bubble-free
Air bubbles block ultrasound waves; vacuum mixing and deaeration before filling.
Stable viscosity
Stays on the examination area and glides smoothly; stable across temperatures and between batches.
Probe compatibility
Free of ingredients that damage probe materials; alcohol-free.
Easy to wipe, no staining
Wipes off with a dry cloth, leaving no residue on skin or fabric.
Three formulation directions
Three common types of ultrasound gel
Medium-viscosity gel
For general ultrasound use.
High-viscosity gel
Adheres well to curved areas, with little running.
Gel for aesthetic devices
Used with ultrasound and radiofrequency devices in spas — classification is determined by intended use.
Packaging is planned with the formula
Nozzle-cap bottles, large containers, pouches for gel warmers.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters monitored during formula development. Parameters for the medical device dossier are applied according to the relevant standards and regulations.
- pH
- Measured at manufacture and after aging.
- Viscosity
- Across temperatures and between batches.
- Air bubbles, clarity
- Visual inspection, including under light.
- Microbiology
- Tested at a GLP / ISO 17025-accredited laboratory.
- Preservative performance
- Preservative efficacy (challenge) test for large containers.
- Packaging compatibility
- Nozzle-cap bottles do not leak; containers seal tightly.
Claims
Writing claims in line with the medical device dossier
The intended use stated on the label determines the product's classification and dossier.
Coupling gel for ultrasound
Intended use as stated in the dossier.
Bubble-free, non-greasy
Description of properties.
Alcohol-free
State only the ingredients actually present.
Directions
Apply a sufficient layer to the examination area; wipe clean after use.
Warnings
For external use only; avoid the eyes; discontinue use if irritation occurs.
Storage
Store in a cool place; close the container tightly after use.
Manufacturing specifications
Scope of cooperation
- Texture
- Clear aqueous gel.
- Format
- Nozzle-cap bottles, large containers, pouches. Volume agreed during packaging selection.
- Product category
- Medical device — not covered by the cosmetic product notification.
- Manufacturing and documentation
- Classification, manufacturing requirements and the medical device registration dossier are discussed separately for each project.
- Minimum order quantity
- Agreed per order.
- Packaging
- Label design following the mandatory content for medical devices, printing and packing.
Suggested product concept
Clear, medium-viscosity ultrasound gel
A product concept to help you picture the possibilities — not a ready-made product for sale. The actual formula is developed in line with the medical device dossier.
Clear light blue gel
Easy to identify, bubble-free.
Medium viscosity
Glides smoothly without running.
Alcohol-free
Compatible with probes.
250 ml bottle and 5-liter container
Nozzle-cap bottle for the examination table, container for storage.
Customization options
What you can specify
Within the same product type, each user facility has different needs. Tell us your requirements in the areas below, and our team of pharmacists will advise on a matching solution.
Viscosity
Medium or high.
Color
Colorless or light blue.
Purpose
Diagnostic ultrasound, aesthetic devices.
Channel
Hospitals, clinics, spas.
Documentation
An existing medical device dossier, or a new one to be prepared.
Packaging
Nozzle-cap bottles, containers, pouches for gel warmers.
Further reading
Related topics
Moisturizing gel manufacturing
Aqueous gel technology used in cosmetics.
Hand sanitizer manufacturing
A product used in clinics.
Intimate moisturizing gel manufacturing
The line between cosmetic gels and medical device gels.
Cosmetic labeling rules
How cosmetic labels differ from other product categories (in Vietnamese).
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details (in Vietnamese) →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
Head office: Huu Le village, Dai Thanh commune, Hanoi · Factory: Thanh Oai Industrial Cluster, Binh Minh commune, Hanoi, Vietnam
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