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Regulatory Affairs |
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The VariaCardio® TF5 is manufactured
by MIE Medical Research Ltd on behalf of AMDG. MIE has ISO13488
accreditation and is a FDA registered Manufacturer.
The VariaCardio® TF5 is CE certified as required by the
European Medical Devices Directive. An FDA 510k application
has been made and we are waiting for their response.
 MIE Medical Research Ltd is an ISO13488 accredited company. For
more information on MIE you may view their web-site at: www.mie-uk.com
CE0120, FDA 510k registered, EN60601-1:1993, EN6061-1-2:1993,
EN61000-2:1995, A12:1996, A1:1998, A2:1998, A14:2000. EN61000-3-3:1995.ETSI
EN 300220-3 V1.1.1 (2000-09). ETSI EN 301 489-3 V1.2.1 (2000-08).
FCC CFR47 parts 15.249, FCC CFR47 parts 15.109.
The Product is manufactured in accordance with the Medical Devices
Directive 93/42/EEC and quality sytems ISO 13488. |
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All material contained
within this website is copyrighted to Advanced Medical
Diagnostic Group Limited.
VariaCardio® and VariaPulse are registered trademarks
of AMDG Ltd. This product is protected by patents owned
by AMDG Ltd.
Manufactured for AMDG by MIE Medical Research Ltd (an
ISO13488 accredited company). AMDG and MIE Research Ltd
reserve the right to amend specifications without notice
in accordance to their policy of continual product improvement. |
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| © 2001-5
Advanced Medical Diagnostics Group Ltd. All Rights Reserved.
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| AMDG Ltd,
6 Wortley Moor Road, Leeds, LS12 4JF
Tel: +44 (0) 113
279 1010 Fax: +44
(0) 113 231 0820
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