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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

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

View Certificate of Registration

FDA Device Listing - APRU-6L

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

View FDA Listing

MET Safety Certifiction

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

View MET Certificate

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

View FDA Registration

FDA - Certificate to Foreign Government

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

View FDA Certificate

FAA Helicopter Air Ambulance Qualified - APRU-6L

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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
Government

International

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