Certifications &
Registrations
Delta’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 Government
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.
FEI Number: 3017667916
The APRU-6L is a listed medical device with the U.S. Food & Drug Administration.
GUDID Listing
The APRU 6L meets USA CFR Title 21 Part 15B and Canada ICES 003 for wireless 4.2 GHz module operation.
The APRU is Safety Certified to the UL/IEC 61010-1 Standard by Eurofins MET Labs.
International Certifications
This document shows that our products are legal to be marketed in and exported from the USA.
The APRU-6L is marketed in the EU with a CE mark for a “Temperature Regulated Laboratory Storage Device.”
