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Certifications

Certifications: Action Medical operates its facility in India. This facility has been constructed as per Schedule M-III of the Indian FDA and CDSCO, which is the apex body in India for Medical Devices and Drugs. This facility is audited & approved by FDA.

European Standards : In addition, Action Medical has appointed DNV-GL, Norway as its Notifying Body for compliance to European Standards. DNV-GL audits our facility & processes regularly for due compliance to various requirements as per MDD directives. Our manufacturing facility is ISO-9001:2008 / 13485:2003 certified. The products range has been CE marked / certified by DNV-GL.

US-FDA : Some of our product ranges like the PrecisionCut Surgical Instruments / knives / Blades are registered with US-FDA as well. This allows us to export to USA.

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