Pacific Knowledge Systems Product and Regulatory Information

Manufacturer Information
RippleDown, AlinIQ CDS and LABOSYS CDS are manufactured by Pacific Knowledge Systems Pty Ltd.

Registered Office US Agent
Pacific Knowledge Systems Pty Ltd
Suite 310,
50 Holt Street,
Surry Hills, NSW, 2010,
Australia
Email: support@pks.com.au
Tel: +61 2 8313 9990
Emergo Global Representation LLC
2500 Bee Cave Road,
Building 1, Suite 300,
Austin, Texas 78746,
United States
Email:usagent@emergogroup.com
Tel: +1 512 327 9997

External Certification
Pacific Knowledge System Proprietary Limited quality system has been certified as conforming to the requirements of:

  • ISO 13485:2016 (Medical Device Directive) by BSI Healthcare (Notified Body 0086) Medical Devices Certification, BSI Healthcare, Kitemark Court, Davy Avenue, Milton Keynes, MK5 8PP, UNITED KINGDOM
  • ISO 9001:2015 by BSI Healthcare (Notified Body 0086) Medical Devices Certification, BSI Healthcare, Kitemark Court, Davy Avenue, Milton Keynes, MK5 8PP, UNITED KINGDOM

US Regulatory Clearance
Agency: Food and Drug Administration (FDA)
Register: Establishment and Device Listing database
Listed entity: Pacific Knowledge Systems Pty Ltd
Product: AlinIQ CDS
Class: Class 1, 510(k) exempt
Listing number: D304123
Registered Establishment number: 3013952181
Owner/Operator number: 10055855

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