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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 on the FDA's own website. 

ISO 13485:2016

ISO 13485_2016.jpg

Delta Development Team Inc. has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of ISO 13485:2016.

FDA Device Listing - APRU-6L


The APRU-6L is a listed medical device with the U.S. Food & Drug Administration.

GUDID Listing

MET Safety Certifiction


The APRU is Safety Certified to the UL/IEC 61010-1 Standard by Eurofins MET Labs.

FCC and ICES Declaration of Conformity - APRU-6L


The APRU 6L meets USA CFR Title 21 Part 15B and Canada  ICES 003 for wireless 4.2 GHz module operation.

UK Declaration of Conformity


The APRU-6L is marketed in the UK with a UKCA mark for a "Temperature Regulated Laboratory Storage Device."

Canada Statement of Conformity


Click the button below to read the APRU6L Canada Statement of Conformity.

FDA Establishment Registration


Delta Development Team Inc. is registered with the U.S. Food & Drug Administration. 

FEI Number: 3017667916

FDA - Certificate to Foreign Government


This document shows that our products are legal to be marketed in and exported from the USA.

FAA Helicopter Air Ambulance Qualified - APRU-6L


The APRU-6L meets Helicopter Air Ambulance (HAA) Equipment Requirements.

EU Declaration of Conformity


The APRU-6L is marketed in the EU with a CE mark for a "Temperature Regulated Laboratory Storage Device". 

EU and UK F-Gas Regulation NO 517.2014 Conformity


The APRU-6L uses a refrigerant complying with  EU and UK F-Gas Regulation NO 517.2014

United States
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