Certifications

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 ICE-2L 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.

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

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.”

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

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

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

The APRU and its refrigerant are not considered hazardous material per the ICAO DOC 9284 or USA 49 CFR regulations.
Click the button below to view the certificate of regulatory compliance for both APRU & ICE2L.