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Certifications & Registrations

Delta Development Team provides FDA-listed medical devices, rigorously safety-tested by Nationally Recognized Testing Laboratories. Only FDA-registered facilities, such as Delta Development Team, are legally authorized to manufacture blood refrigerators. Explore our certifications below or request access to our Trust Center for a comprehensive view of our compliance, cybersecurity, and operational controls.

General Certifications & Standards

  • Certificate of Regulatory Compliance: General verification of meeting industry standards.

  • Blood Bank Compliance: Documentation ensuring adherence to blood storage protocols.

  • AABB Standards-Compliant: Meets the requirements set by the Association for the Advancement of Blood & Biotherapies.

  • CMMC Compliance: Cybersecurity Maturity Model Certification for safeguarding sensitive data.

  • ISBT-128 Supported Product: Uses the global standard for the identification and labeling of medical products of human origin.

  • ICCBBA Licensed Vendor: Authorized to use the ISBT 128 data standard.

  • Made In USA: Certified domestic manufacturing.

United States Certifications

  • ISO 13485:2016: Quality management systems for medical devices.

  • FDA Establishment Registration: Legally authorized facility for manufacturing blood refrigerators.

  • FDA Device Listings: Specific listings for the APRU-6L and DeltaICE 2L.

  • FCC & ICES: Declaration of Conformity for electromagnetic interference standards.

  • MET Safety Certification: Tested to UL/IEC 61010-1 standards by a Nationally Recognized Testing Laboratory.

  • FAA Helicopter Air Ambulance Qualified: Certified for use in emergency medical flight environments.

  • US Army Air Worthiness: Qualified for use on Blackhawk helicopters.

International Certifications

  • Certificate to Foreign Government: Facilitates the export of medical devices.

  • EU & UK Declaration of Conformity: Meets European and British safety and environmental requirements.

  • EU F-Gas Regulation NO 2024/573: Compliance with fluorinated greenhouse gas regulations.

  • Canada Statement of Conformity: Meets Canadian regulatory requirements.

  • ICAO/49 CFR: Certified for transport in checked baggage.

Note: For more detailed documentation, the company provides a Trust Center where you can log in to view specific compliance and operational controls.