Regulatory Documents

FDA & ISO

• EC Certificate
• EN ISO 13485 Certificate
• Status of Maxtec’s EN ISO 13485 Certificate
• Maxtec EN ISO 13485:2016 Recertificate Audit – Bridge Letter

Certificates

• Line Power Supply Certificate
• MDSAP Certificate

Declarations of Conformity

• 2-in-1 Muffled Adapter
• Blender Buddy, Blender Buddy 2
• Blend Up Kit
• EyeMax 2
• Acrylic Flow Meter
• Flowmeter Family
• Flowmeter Manifold
• KOH Sensors
• MaxBlend 2 Family
• MaxFLO2
• MaxO2+/Handi+ Family
• MaxO2 ME
• MaxVenturi
• MicroMax
• Oxygen Sensors (IT)
• Oxygen Sensors (Weak Acid)
• SmartStack Patient Care Stand
• UltraMaxO2

Material Safety Data Sheets

• Safety Data Sheet 01
• Safety Data Sheet 02

Quality Letters

• Latex & Mercury Free
• Latex Free Form Letter

Conflict Materials

• Conflict Materials Statement