Certifications & Safety Testing

 

FDA Facility Registration

Our manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA), and BooBoo Coolers™ are listed with the FDA as medical devices. This confirms that both the manufacturing facilities and the product meet applicable FDA requirements for medical device establishment registration and device listing.

FDA registration and listing do not constitute FDA approval or endorsement, but they demonstrate compliance with the regulatory obligations required for manufacturing and distributing medical devices in the United States.

ISO 13485 Certification
Our facilities are certified under ISO 13485:2016, the internationally recognized quality management standard for medical devices. Issued by BSI, this certification covers the design, development, manufacture, and distribution of both sterile and non-sterile dressings, bandages, and related products. 

 

GMP Compliance
Our manufacturing facilities operate in compliance with Good Manufacturing Practice (GMP) standards, certified by independent bodies such as SGS and BSI. This ensures that every product is produced under strict quality controls, with processes that meet internationally recognized requirements for safety, hygiene, and consistency.

 

 

Independent Product Safety Testing

In addition to our manufacturer’s internationally recognized certifications, BooBoo Cooler has been independently tested by STQ Testing Services (V-Trust Group) to verify product safety. The bandages were evaluated against U.S. children’s product safety standards, including the Consumer Product Safety Improvement Act (CPSIA) and the more stringent California Proposition 65 requirements. These tests screen for harmful substances such as lead, cadmium, and phthalates, which are strictly regulated in children’s products.

All results were PASS, with no detectable levels of restricted heavy metals or phthalates. This confirms that BooBoo Cooler meets the strict requirements for children’s product safety across the United States, and is even compliant with the additional safety requirements enforced in California, one of the most regulated markets in the world.