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Regulatory/QA
 

This page contains information regarding AtCor Medical Quality Assurance status and Product Regulatory Approvals.

Quality Assurance

AtCor Medical's 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.

Quality Policy Statement

SGS ISO13485:2003 Certificate

SGS ISO9001:2000 Certificate

 

Electrical Safety & EMC

All AtCor Medical products have been tested and approved to the following Electrical Safety & EMC Standards:

IEC60601-1:1998 AS/NZS 3200.1.0:1998 Medical electrical equipment Part 1:General requirements for safety

 

IEC60601-1-2:1993 Medical electrical equipment –Part 1-2. General requirements for safety- Collateral standard: Electromagnetic compatibility-Requirements and tests.

Test Reports can be supplied upon request.

 

Certificates:

 

Module Model IEC6060-1* IEC6060-1 CB AS/NZS3200.1
MM3
MM2 -

EM2

-

* Test Report Cover Page Only, Full report can be supplied upon request.

 

Regulatory

 

Australia (TGA)

Products are listed on the Australian Therapeutic Goods Register, ARTG Listing number  AUST L 64615.

TGA Certificate of Listing

 

Europe

The following products are approved for import into the EU.

Classification: Class IIa

Directive: MDD 93/42/EEC

Assessment Route: Annex II

 

SCOR-Px Pulse Wave Analysis System

SCOR-Vx Pulse Wave Velocity System

SCOR-Mx Pulse Wave Monitoring System

SGS MDD Certificate GB00/51436

EC Declaration of Conformity

EU Authorised Representative

AtCor Medical (UK) Ltd

C/- Scanmed Medical Instruments

Cotswold Business Village

Moreton-in-Marsh, Gloucestershire

GL56 0JU, England, UK

Tel: +(44) (1608) 653345

Fax: +(44) (1608) 653346

USA (FDA)

 

SCOR-Px Pulse Wave Analysis System

K012487
SCOR-Mx Pulse Wave Monitoring System K002742

 

 

Canada

The following products have a Medical Device License for import into Canada.

SCOR-Px Pulse Wave Analysis System

Medical Device License

ISO13485 Certificate CMDCAS

SCOR-Vx Pulse Wave Velocity System
SCOR-Mx Pulse Wave Monitoring System
Tonometer SPT-301B

 

 

China

Below is the Medical Device Registration Certificate for AtCor Medical from the SDA.

SDA Registration Certificate

Korea

Below is the KFDA Medical Device Import Permit for AtCor Medical.

KFD Import Permit