This page contains information
regarding AtCor Medical Quality Assurance status and
Product Regulatory Approvals.
manufacturing plant, which is based in Sydney Australia, is
certified to ISO9001 & ISO13485 Quality Management System for Medical
Device Manufacturers. Assessment and Certification is
provided by SGS Yarsley.
Electrical Safety & EMC
AtCor Medical products have been tested and approved
to the following Electrical Safety & EMC Standards:
IEC60601-1 Medical electrical
equipment Part 1:General requirements for safety
Medical electrical equipment –Part 1-2.
General requirements for safety- Collateral
standard: Electromagnetic compatibility-Requirements
Test Reports can be supplied upon
are included on the Australian Therapeutic Goods
Register, ARTG Number 152313.
The SphygmoCor Cardiovascular Management Suite (CvMS) is
approved for import into the EU.
Classification: Class IIa
Directive: MDD 93/42/EEC
Assessment Route: Annex II
SGS MDD Certificate GB00/51436
EC Declaration of Conformity
EU Authorised Representative:
Thorne Widgery House
33 Bridge Street, Hereford
HR4 9DQ, England, UK
+(44) 845 094 3307 Facsimile: +(44)
(0) 156 862 0078
The SphygmoCor CvMS has FDA 510k-clearance
USA Agent Information
AtCor Medical Inc.
One Pierce Place, Suite 295-East
Itasca, IL, 60143, USA
The SphygmoCor CvMS product has a Medical Device License for
import into Canada.
The SphygmoCor CvMS has Chinese SFDA approval.
The SphygmoCor CvMS has a KFDA Medical Device Import Permit.
The SphygmoCor CvMS is registered with the MHLW in Japan.