CERTIFICATE - Nethouse · 2015. 2. 2. · light therapy devices - Bioptron2lB.2 - Bioptron Compact...
Transcript of CERTIFICATE - Nethouse · 2015. 2. 2. · light therapy devices - Bioptron2lB.2 - Bioptron Compact...
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CERTIFICATEfor the
Quality Assurance System
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KRAf icqtion
As a notified body of the European Union (Reg" No. 0124) DEKRA Certification GmbHhereby approves the Quality Assurance System applied for design, manufacture and final
inspection by the company
BIOPTRON AG
Sihleggstraße 23 I 8832 Wollerau, Switzerland
Approval is based on the decision dated 18.07.200B and the result of the repoñno. 50344-2,3-00 and is performed in accordance with the stipulations of
Annex ll, Section 3 of the Directive 93/42|EECof the Council dated June 14, 1993 governing medical devices. The certification is applicable to thedevices specified in the Annex. The devices in question are subjected to testing and examination inaccordance with Annex ll, Section 3 of the Directive 931421ÊEC. The listed devices may be affixed
with the CE marking indicated below.
C € 0124
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DECerti
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Date of the lastrecertification:
Certificate-registration No.:
21.07.2008
50344-1 6-03English version(duplicate)
** *** Akkreditiert durch* i' Zentrâlstelle der Länder* ELG ¡ 'u'o".,'.TX:?åìåîUi;x . tt und Med¡z¡nprodukten** * ** zLG-zQ-992.94.16
Date of the firstcertification:
This certificate isvalid until:
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Annex to the Gertificate 50344-16-03 dated 18.07.2008English version
Revision status: 1 Date: 18.09.2009 Page 1 of 1
Devices/device cateqories included in the certificate
Class ll a:
light therapy devices
- Bioptron2lB.2- Bioptron Compact lll i BC lll- Bioptron Pro 1 lBProllndications for use of the Bioptron Light therapy devices:
Wound healing in venous leg ulcers, pressure sores, burns. Pain treatment inRheumatology, Physiotherapy, sports medicine. Dermatological disorders and skinproblems (acne, herpes, psoriasis). Dermal affections in newborns. In Pediatrics-Musculoskeletal and Allergic respiratory disorders, dermal affections. Seasonalaffective disorders (mild depressions, sleep disorders, chronic fatigue syndrome).
This document may only be reproduced and distributed complete!
DEKRA Certificcriion GrirbH . llcndwerkstrcrße l5 . D 7O565 Stullgcrrt . www.clekrc'ccrlificotion.corn
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