CERTIFICATE for the Quality Assurance System ++11"** KRA f icqtion As a notified body of the European Union (Reg" No. 0124) DEKRA Certification GmbH hereby 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 repoñ no. 50344-2,3-00 and is performed in accordance with the stipulations of Annex ll, Section 3 of the Directive 93/42|EEC of the Council dated June 14, 1993 governing medical devices. The certification is applicable to the devices specified in the Annex. The devices in question are subjected to testing and examination in accordance with Annex ll, Section 3 of the Directive 931421ÊEC. The listed devices may be affixed with the CE marking indicated below. C € 0124 * DE Certi * * * * + * * Date of the last recertification: Certificate- registration No.: 21.07.2008 50344-1 6-03 English 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 first certification: This certificate is valid until:

CERTIFICATE - Nethouse · 2015. 2. 2. · light therapy devices - Bioptron2lB.2 - Bioptron Compact lll i BC lll - Bioptron Pro 1 lBProl lndications for use of the Bioptron Light therapy

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CERTIFICATEfor the

Quality Assurance System

++11"**

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

*

DECerti

**

**+*

*

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:
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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