Certifications & Safety Testing

 

FDA Facility Registration

Our manufacturing facilities are registered with the U.S. Food and Drug Administration (FDA), confirming compliance with FDA requirements for medical device establishments. While FDA registration does not imply product endorsement or approval, it demonstrates that our products are produced in facilities that meet the necessary regulatory obligations for manufacturing and device listing. The BooBoo Cooler itself is not classified as a medical device, as it’s not sterile, but it is produced in FDA-registered facilities under these regulatory standards.

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. While BooBoo Cooler is not a sterile medical device, it is produced in facilities that maintain ISO 13485 certification, ensuring consistent quality, safety, and compliance with global medical device standards.

 

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.

 

EU Quality Management System Certificate

Our manufacturing partner, is certified under the EU Medical Device Regulation (MDR 2017/745) by BSI Group (Notified Body 2797). This certification confirms that the company’s quality management system meets rigorous European standards for the design and manufacture of medical products, including dressings and plasters. Valid through February 2030, this approval demonstrates adherence to internationally recognized processes for consistency, safety, and regulatory compliance in medical device production. BooBoo Cooler is not a sterile medical device, but is produced in facilities that comply with MDR quality standards.

 

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.