EC DECLARATION OF CONFORMITY CERTIFICATE

Transcription

1 EC DECLARATION OF CONFORMITY CERTIFICATE We, the company Össur hf, Grjothals 1-5, 110 Reykjavik, Iceland, hereby declare on our own responsibility that the following Class I, Class IIa and Class IIb product ranges meet all applicable Essential requirements of the Medical Device Directive 93/42 EEC in Annex I. Class I products follow the procedure set out in Annex VII and Class IIa and Class IIb products follow the procedure set out in Annex II. Össur runs a quality system according to ISO 9001:2008 and ISO 13485:2012 Should you require more detailed information regarding this EC declaration of conformity, please contact Össur Head Office. This declaration is valid from June the 10 th It was last upd June 8 th Jóhanna Valdimarsdóttir Quality Assurance Director ÖSSUR

2 Ankle AFO Dynamic May.2005 I Ankle AFO Light May.2005 I Ankle Airform Ankle Stirrup bef.2005 I Ankle Airform Universal Inflatable Stirrup Ankle Brace Jul.2005 I Ankle Equalizer Walker bef.jun I Ankle Equalizer Air Walker bef.jun I Ankle Exoform Ankle Brace Mar June.2012 I Ankle Foam Ankle Stirrup bef.2005 I Ankle Foot-Up bef.2005 I Ankle Form Fit Ankle I Ankle Form Fit Ankle Brace 11.Feb.11 I Ankle Form Fit Ankle with Figure I Ankle Form Fit Ankle with Speedlace I Ankle Form Fit Foam Ankle Brace Jan.1996 I Ankle Form Fit Night Splint 29.March.10 I Ankle Form Fit Night Splint June.10 I Ankle GameDay Ankle Brace 14.Nov.07 I Ankle Rebound Ankle Brace 1.Jan.10 I

3 Ankle Rebound Air Walker 25.May.10 I Ankle Rebound Air Walker Euro 20.Jun.12 I Ankle Rebound Air Walker Low Top 28.Oct.10 I Ankle Rebound Foot-Up 25.Jan.17 I Arm Bergschultz Universal Arm Sling bef.2005 I Arm Innovator X Post-Op Elbow Brace 1.Nov.06 I Arm Premium Contact Closure Arm Sling bef.2005 I Double Brace bef.2006 I Form Fit Brace I Form Fit Brace with Abduction I Form Fit Brace with External Rotation I Form Fit Tennis Elbow 2.Jan.12 I Monitor Arm Sling bef.2006 I Mx Elevator Sling bef.2006 I Premium Immobilizer bef.2005 I Abduction Wedge bef.2005 I

4 Smartsling bef.2005 I Sub-Lux Cuff bef.2006 I Back Airform Inflatable Back Support bef.2005 I Back Form Fit Advance Back bef.2005 I Back Form Fit Industrial Back Support bef.2006 I Back Thera Back Back Support bef.2006 I Back Tri Back bef.2005 I Casting & Splinting Casting & Splinting Casting & Splinting Casting & Splinting Casting & Splinting Casting & Splinting Techform I Cast Tape bef Aug I Techform II Cast Tape 1.Jan Oct I Techform Ortho-Roll 1.Jan.2006 I Techform Pre-Cut Splints 1.Jan.2006 I Techform Premium Cast Tape 1.Jul.2010 I Techform Standard Cast Tape 1.Jul.2010 I Clavicle Figure 8 Clavicle Splint bef.2005 I Clavicle Front Closure Clavicle Support bef.2006 I Clavicle Universal Elastic Rib Belt bef.2006 I Elbow Airform Tennis elbow bef.2005 I

5 Elbow Elbow Brace LP bef.2005 I Elbow Neoprene Tennis Elbow Support bef.2005 I Hand Abducted Wrist / Thumb Wrap bef.2006 I Hand Elastic Thumb Spica bef.2005 I Hand Form Fit Thumb Spica bef.2005 I Hand Form Fit Thumb Spica Universal I Hand Form Fit Thumb Spica with Gel I Hand Form Fit Universal Thumb Brace 9.Jan I Hand Unloader Thumb Day 3.Dec.14 I Hand Unloader Thumb Night 3.Dec.14 I Hand Universal Thumb Spica 1.Apr.07 I Hip Hiptric 1.Feb.09 I Hip Unloader Hip 27.Jun.13 I Foot Airform Night Splint bef.2005 I Foot AFO Leaf Spring bef.2005 I Foot Dorsal Night Splint Aug.08 I Foot DH Offloading Walker bef.2005 I Foot Form Fit Night Splint Posterior I Foot Rebound Diabetic Walker 2.Apr.14 I

6 Foot ROM Walker bef.2005 I Knee Deluixe Knee Immobilizer Jan.06 I Knee CTi Custom Apr.07 I Knee CTi OTS Apr.07 I Knee CTi Vapor Feb.2008 I Knee Extreme bef.2005 I Knee Exoform Knee Immobilizer bef.2005 I Knee Flex Apr.07 I Knee Form Fit 16 Post Op Knee Full Foam I Knee Form Fit 24 Post Op Knee Full & Cool Foam I Knee Form Fit 28 Post Op Knee Full & Cool Foam I Knee Form Fit Knee 26.May.11 I Knee Form Fit Knee Hinged Lateral J I Knee Form Fit Knee Hinged Sleeve I Knee Form Fit Knee Hinged Wrap I Knee Form Fit Knee Immobilizer Universal I Knee Form Fit Knee MCL I Knee Form Fit Knee ROM 12 Sleeve I

7 Knee Form Fit Knee ROM 16 Sleeve I Knee Form Fit Knee ROM 12 Wrap I Knee Form Fit Knee ROM 16 Wrap I Knee Form Fit Neoprene Hinged Knee Support bef I Knee Form Fit OA Wraparound 26.May.15 I Knee Paradigm OTS 10.Jun.05 I Knee Patella Cup 31.Des.13 I Knee PCL Pad Accessory kit 14.Jan.15 I Knee PFOA 22.Oct.14 I Knee Rebound DUAL 5. August 15 I Knee Rebound Knee Brace 28. Jul. 11 I Knee Rebound ACL 9. Sept. 14 I Knee Rebound PCL 22. Oct. 14 I Knee Rebound Cartilage 28. Jun. 13 I Knee Rebound Cartilage Custom 5. Marz 15 I Knee Rebound Post-Op Knee I Knee Thermowrap Jan. 05 I Knee Trainer 10. Jun. 05 I

8 Knee Trainer OA 16. Nov I Knee Innovator Bef I Knee Innovator DLX 9. Oct. 06 I Knee Innovator DLX Oct. 12 I Knee MVP Contour Brace 18. Apr Apr. 16 I Knee Neoprene Wraparound Hinged Knee Support bef I Knee Rehab bef I Knee OAsys CARTICARE bef I Knee Universal 3-Panel Knee Immobilizer bef I Knee Unloader ADJ bef I Knee Unloader Custom bef I Knee Unloader Express bef I Knee Unloader FIT 2.Jul.14 I Knee Unloader Lite bef.2005 I Knee Unloader One Lite I Knee Unloader One OTS 19.Oct.10 I Knee Unloader One Custom 19.Oct.10 I Knee Unloader One Plus 20.June.11 I

9 Knee Unloader PF 10. May 16 I Knee Unloader Select bef.2005 I Knee Unloader Spirit bef.2005 I Knee Unloader One SmartDosing 5.Sept.12 I Knee Unloader XT bef.2005 I Knee Undersleeve 8.April.13 I Knee Ultrawrap bef.2005 I Knee Velsplint Knee Immobilizer bef.2005 I Other Braun Frame Jan.2010 I Other Canvas Rocker Bottom Cast Shoes bef.2006 I Other Insoles bef.2005 I Other DH Offloading Post-Op Shoe Jan.2010 I Other Thomas Splint 20.Oct.2003 I Other Constant Force Caliper 27.Jun.2013 I Spinal Assist 8 Extra bef.2006 I Spinal Atlas bef.2005 I Spinal Dual Maternity Belt bef.2006 I Spinal EMT s Choice bef.2005 I Spinal Foam Cervical Collar Jan.2009 I

10 Spinal Form Fit Back Support 7.Feb.17 I Spinal Form Fit Back Support Air 7.Feb.17 I Spinal Form Fit Lumbar 19.Dec.14 I Spinal JTO Thoracic Extension bef.2005 I Spinal Hip-y jan.2006 I Spinal Miami J bef.2005 I Spinal Miami J Advanced 14.Jul.10 I Spinal Miami Jr bef.2005 I Spinal Miami LSO 22.Feb.2017 I Spinal Miami Lumbar TLSO 25.Mar.2010 I Spinal Miami Lumbar 1.Jan.2010 I Spinal Miami Lumber Posteo 9.Nov.12 I Spinal Miami Lumbar Slim 17.May.2011 I Spinal NecLoc bef.2005 I Spinal NecLoc Kids bef.2005 I Spinal Occian Back bef.2005 I Spinal One-Piece bef.2005 I Spinal Papoose bef.2005 I Spinal Patriot bef.2005 I

11 Spinal Philadelphia Adjustable 2.Feb.12 I Spinal Philadelphia Halo bef.2005 I Spinal Philadelphia Stabilizer bef.2005 I Spinal Philadelphia Tracheotomy Collar May.2007 I Spinal Rebound Hip 11.Jan.2013 I Spinal ReSolve Halo Vest 30.mars.10 I B&D Spinal Temporary Hernia Support bef.2006 I Spinal Universal Abdominal Binder bef.2006 I Spinal Velastic Plus 15.July.10 I Wrist Carp-X bef.2005 I Wrist Exoform Wrist 1.Feb.05 I Wrist Exoform Carpal Tunnel Wrist bef.2005 I Wrist Form Fit Universal Wrist Brace 9.Jan I Wrist Form Fit Wrist I Wrist Form Fit Wrist & Forearm Universal I Wrist Form Fit Wrist with Gel I Wrist Form Fit Wrist Brace bef.2005 I Wrist Form Fit Wrist & Forearm I

12 Wrist Form Fit Wrist & Forearm Universal I Wrist Form Fit Wrist & Forearm with Gel I Wrist Form Fit Wrist Universal I Wrist Neoprene/Elastic Wrist Thumb Brace bef.2005 I Wrist Simpla Wrist Support bef.2005 I Wrist Spectra Wrist Brace 1.Aug.08 I Wrist Thermobrace bef.2005 I Wrist Universal Wrist Brace April.2006 I

13 Spinal Lil Angel Halo bef.2005 Spinal ReSolve Halo bef.2005 Spinal J-Tongs bef.2005 Spinal Halo accessories bef.2005 Class I sterile, IIa, IIb Class I sterile, IIa, IIb Class I sterile, IIa, IIb Class I sterile, IIa, IIb products Ankle OSSUR Spring bef I Foot OSSUR Footplate Tapered bef I Knee Edge Apr Dec.2007 I Knee 3DX 10.Jun I Knee Morph Apr.07 1.Jul.2008 I Other Ossur Cosmetic Foam 1.Aug.04 bef.jun.2008 I Other OSSUR Foam Plate bef.oct.03 bef.jun.2008 I Other OSSUR Silicone Padding Plate bef.oct.03 bef.jun.2008 I Abbreviations: P: Prosthetics : Braces and supports OTS: Off the shelf LP: Low profile AFO: Ankle Foot Orthosis

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