Certifications &
Registrations
DDT’s medical devices are FDA listed and safety tested by a Nationally Recognized Testing Laboratory. Only FDA registered facilities are legally allowed to manufacture blood refrigerators. Click these links to see the official registration information or document.
United States GovernmentÂ
Delta Development Team Inc. has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of ISO 13485:2016.
Delta Development Team Inc. is registered with the U.S. Food & Drug Administration.Â
FEI Number: 3017667916
The APRU-6L is a listed medical device with the U.S. Food & Drug Administration.
The ICE-2L is a listed medical device with the U.S. Food & Drug Administration.
The APRU and ICE meet USA CFR Title 47 Part 15. The APRU meets Canada ICES 003 for wireless 4.2 GHz module operation.Â
The APRU & ICE are Safety Certified to the UL/IEC 61010-1 Standard by Eurofins MET Labs.
Approved for Airworthiness – The APRU-6L-2 is listed in the Army AWR 1930, Revision 26. It’s authorized for use on board UH-60L, UH/HH-60M, and UH-60V Army helicopters in battery powered mode.
International Certifications
This document shows that our products are legal to be marketed in and exported from the USA.
The APRU-6L and ICE-2L are marketed in the EU with a CE mark for a “Temperature Regulated Laboratory Storage Device.”
The APRU-6L is marked in the UK with a UKCA mark for a “Temperature Regulated Laboratory Storage Device.”
