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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.
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:
* 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
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)
Canada
The
following products have a Medical Device License for
import into Canada.
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
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Quality Assurance
