Document library

Essential Documents.

Library of device documents for patients, healthcare professionals, and pharmacy teams.

Document library

Device documents.

Product documents for understanding the Grenco Medical Elite II device, its intended use, setup, warnings, specifications, and support information.

User manual

Grenco Medical Elite II Instructions for Use V2.3

The official user manual for intended use, safety warnings, setup, operation, cleaning, device specifications, support contacts, and standards.

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Regulatory documents

Regulatory records.

Public regulatory references and uploaded certification records for the Grenco Medical Elite II. Current certification references include Australia ARTG Entry 526764 · Class IIb medical device, Health Canada HC MDL 113029, Medsafe NZ WAND registered, and MDSAP · ISO 13485 manufacturing certification.

Official TGA link

ARTG Entry 526764 Public Summary

Official public TGA record for Mood State Medical Pty Ltd, device class, sponsor details, and intended purpose.

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Government source copy

Uploaded ARTG Summary PDF

Downloadable copy of the ARTG summary for document reference.

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Certificate

TGA Conformity Assessment Certificate AU Q00557

Version 1.1, issued 12 May 2026, certificate scope for heated ambulatory nebulizer Class IIb.

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