Company Milestones
Company Milestones
2005-2014
• 2005 - WOFE business license
• 2006 - TUV ISO 13485 for compressor nebulizers
• 2007 - TUV ISO 13485 for breast pumps
• 2008 - Import/export license
• 2008 - CFDA approval for AG EDGE and AG CLASSIC under Medel Italy
• 2011 - CFDA approval for AG EDGE and AG CLASSIC under Mel Medical
• 2014 - TUV ISO 13485 and CE audit under Globalcare
• 2014 - CFDA registration for three compressor nebulizers in China

2015-2019
• 2015 - BSCI audit
• 2016 - Safety Bureau inspection
• 2017 - TUV ISO 14001 certification
• 2017 - FDA audit with EIR for compressor nebulizers
• 2018 - CE marking extended to thermometers, ECG devices, and medical lamps
• 2019 - FDA 510(k) clearance for breast pumps

2020-Present
• 2020 - FDA approval for portable DC compressor nebulizer
• 2021 - CE MDR approval for all lines; SA8000 certified
• 2022 - New Xiaolan building expanded capacity
• 2023 - In-house SMT operation began
• 2024 - In-house injection molding operations began
• 2025 - FDA audit successfully completed