Essential for hypertension management.

Regulatory & Quality Assurance

Regulatory

Australia
AtCor Medical products are included on the Australian Therapeutic Goods Register (ARTG Number: 152313).

Europe
The SphygmoCor Cardiovascular Management Suite (CvMS) and SphygmoCor XCEL are CE-marked and approved for import into the European Union.

AtCor Medical’s EU Authorized Representative:
Advena Ltd.
Pure Offices
Plato Close, Warwick
CV34 6WE
United Kingdom

USA
The SphygmoCor CvMS and XCEL have received FDA 510k clearance.

Canada
The SphygmoCor CvMS and XCEL have received Health Canada approval.

Quality Assurance

AtCor Medical’s manufacturing plant is based in Sydney, Australia. The facility is certified to ISO 9001 and ISO 13485 Quality Management Systems for Medical Device Manufacturers and manufactures according to US FDA cGMP requirements.

© 2017 AtCor Medical Pty Ltd.

Most Recent Tweet