质量承诺This page contains information regarding AtCor Medical Quality Assurance status and Product Regulatory Approvals.
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.
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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 |  |
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| MM2 | |
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EM2 |
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* Test Report Cover Page Only, Full report can be supplied upon request.
Australia (TGA)
Products are listed on the Australian Therapeutic Goods Register, ARTG Listing number AUST L 64615.
Europe
The following products are approved for import into the EU.
Classification: Class IIa
Directive: MDD 93/42/EEC
Assessment Route: Annex II
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SCOR-Px Pulse Wave Analysis System |
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SGS MDD Certificate GB00/51436
EU Authorised Representative
AtCor Medical (UK) Ltd
C/- Scanmed Medical Instruments
Draycott Business Centre, Draycott
Moreton-in-Marsh, Gloucestershire
GL56 OJQ, UK
Tel: +(44) 1386 701 700
Fax: +(44) 1386 701 800
USA (FDA)
| K012487 |
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| SCOR-Mx Pulse Wave Monitoring System | K002742 |
Canada
The following products have a Medical Device License for import into Canada.
| 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.
Korea
Below is the KFDA Medical Device Import Permit for AtCor Medical.