Certificates
Supporting the repair and maintenance of patient care equipment for more than 20 years. AIV has obtained the following ISO certifications:
- March 2000 - ISO 9002:1994 Standard.
- March 2004 - ISO 9001:2000 standard
- December 2004 - AIV registers to ISO13485 the international standard for medical device manufacturing, and the highest level of recognition ISO can bestow on a manufacturer of medical devices.
The documents below represent certificates AIV has with each of the major quality system or regulatory bodies. They are available for immediate download.
- Notified Body Registration for CE Marking
- FDA 510(k) letter for Baxter Doors
- FDA 510(k) letter for AIV New FMTs - (FM10835/10836/10839/10840/10841)
- FDA 510(k) letter for AIV New FMTs - (FM10833/10834)
- FDA 510(k) letter for SpO2 Adapter Cables
- FDA 510(k) letter for ECG Cables and Leadwires
- FDA 510(k) letter for Temperature Probes
- UL Listing for Industrial PowerMATE®
- UL Certification for PowerMATE®
- UL Certification for IsoMATE®
- Authorized Representative for Europe
