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Certifications & Registrations

Delta's medical devices are FDA listed and safety certified by ETL. 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.

FDA Device Listing - APRU-6L

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

GUDID Listing

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

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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

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

FDA Establishment Registration

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

FEI Number: 3017667916

ETL Device Listing - APRU-6L

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 The APRU-6L was tested and found to comply with the requirements of the UL-61010-1, -2-11, -2-10  and are identified with the ETL Listed Mark.

FCC and ICES Declaration of Conformity - APRU-6L

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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

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

Canada Statement of Conformity

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

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