DECLARATION OF CONFORMITY
for CE – marking according to Annex II of Medical Devices Directive 93/42/EEC
Manufacturer: |
BTL Industries Limited |
|
Suite 401 Albany House |
|
324-326 Regents Street |
|
London |
|
WIB 3BL |
|
United Kingdom |
The BTL Industries Ltd. herewith declares under its sole responsibility that the product
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Type:
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conforms with the applicable regulation:
Directive:
Quality Assurance Standards:
Procedural Standards:
Date of Issue: 24th February 2004
Place of Issue: London
Combined therapy devices
BTL-5000 Series v1.xx
BTL-4000 Series v1.xx
Electrotherapy devices
BTL-06 v3.xx
BTL-5000 Puls v1.xx
BTL-4000 Puls v1.xx
Ultraound therapy devices
BTL-12 v2.xx
BTL vac v1.xx
Ultraound therapy devices
BTL-07p v4.xx
BTL-5000 Sono v1.xx
BTL-4000 Sono v1.xx
Laser therapy devices
BTL-10 v5.xx
BTL-2000 v5.xx
BTL-5000 Laser v1.xx
BTL-4000 Laser v1.xx
Magnetotherapy devices
BTL-09 v4.xx
Class IIb
MDD 93/42/EEC
ISO 13485 : 2003
EN 60601-1 + A2
EN 60601-1-1
EN 60601-1-2
EN 60601-2-10
EN 60601-2-5
EN 60601-2-22
EN 60825-1
EN ISO 14971
ISO 10993-1
Signature:
Daniela Marx
Director of BTL Industries Limited
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