Dräger - Draeger · Rainer Klug Gert-Hartwig Lescow Dr.Reiner Piske Anton Schrofner Page 1/2. Dräger Director Quality & Regulatory Affairs Business Unit Hospital Consumables & Accessories

DrägerEC Declaration of Conformity Date / DatumEG Konformitätserklärung 2020-01-16(€ European Directive 93/42/EEC, Annex VII European Directive 2011/65/EU

Document ID / Dokument Nr.

Europäische Richtlinie 93/42/EWG, Anhang VII Europäische Richtlinie 2011/65/EU

MD108-010-2001-002-0

Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany

hereby declares under its sole responsibility that the / erklärt hiermit in alleiniger Verantwortung, dass

Product name /Produktbezeichnung

Medical device /Medizinprodukt

DeviceClass

UMDNS Code /GMDN Code

Hook ring (reusable) /Hakenring (wieder verwendbar)

Accessory Anesthesia Masks/Zubehör Anästhesiemasken

I -/37476

Hook ring LITESTAR (single-use) / Hakenring LITESTAR (Einweg)


I -/64198

Hook ring for SediStar (single-use)/ Hakenring für SediStar (Einweg)


I -/64198

Headgear, disposable, soft rubber/ Kopfband, Einweg, weiches Gummi


I 15-230/60882

Headgear, disposable, soft fabric / Kopfband, Einweg, weicher Stoff


I 15-230/60882

meets the provisions of the following European Directives:- 93/42/EEC on medical devices. The procedure according to Annex VII of the above mentioned directive has been followed.- 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment.This declaration is effective for products placed on the market as of the date of issue.Any modifications of the medical device not authorized by Draeger will invalidate this declaration.

DirectorQuality & Regulatory AffairsBusiness Unit Hospital Consumables & Accessories Medical Division

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DirectorResearch & DevelopmentBusiness Unit Hospital Consumables & Accessories Medical Division

Kalle Heckmann

Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211

Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-Code: NOLADE21SPL

Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL

Chairman of the Supervisor^ Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner

mailto:[email protected]

http://www.draeger.com

Dräger

Appendix to EC Declaration of Conformity Date / DatumAnlage zur EG Konformitätserklärung 2020-01-16C€ European Directive 93/42/EECEuropean Directive 2011/65/EU

Document ID / Dokument Nr.

Europäische Richtlinie 93/42/EWGEuropäische Richtlinie 2011/65/EU

MD108-010-2001-002-0-00


Product Name / Produktbezeichnung Medical Device / Medizinprodukt

Hook ring (reusable) /

Hakenring (wieder verwendbar)

Accessory Anesthesia Masks/

Zubehör Anästhesiemasken

Hook ring LITESTAR (single-use) /

Hakenring LITESTAR (Einweg)



Hook ring for SediStar (single-use)/

Hakenring für SediStar (Einweg)



Headgear, disposable, soft rubber/

Kopfband, Einweg, weiches Gummi



Applied Standards in full or in part / Vollständig oder teilweise angewendete Normen:

EN ISO 14971: 2012(ISO 14971:2007 Ed. 2 CORRECTED)

Medical devices - Application of risk management to medical devices

ISO 15223-1: 3ED 2016 COR (EN ISO 15223-1 2016 COR 2017)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1:General requirements.

ISO 10993-1: 2018(EN ISO 10993-1 2009 AC 2010)

Biological evaluation of medical devices - Part 1: Evaluation and testing

IEC 62366-1:2015: COR 1 2015 (EN 62366-1:2015 COR 2016)

Medical devices - Part 1: Application of usability engineering to medical devices

DIN EN ISO 17664:2017 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

ISO 5356-1: 4ED 2015 (EN ISO 5356-1:2015)

Anaesthetic and respiratory equipment - Conical connectors - part 1: Cones and sockets

ISO 18190: 2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment




Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner PiskeAnton Schrofner Page 1/2



Dräger

DirectorQuality & Regulatory Affairs Business Unit Hospital Consumables & Accessories Medical Division

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Timo Harms




Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner PiskeAnton Schrofner Page 2/2



Dräger

Appendix II to EC Declaration of Conformity Date / DatumAnlage II zur EG Konformitätserklärung 2020-01-16C€ European Directive 93/42/EEC

European Directive 2011/65/EUDocument ID / Dokument Nr.

Europäische Richtlinie 93/42/EWGEuropäische Richtlinie 2011/65/EU

MD108-010-2001 -002-0-ECA


Extent of conformity assessment / Umfang der Konformitätsbewertung

Part No. / Sachnr.

Product name / Produktbezeichnung

MP01551 Hook ring LITESTAR,15mm,conn.

MP01552 Hook ring LITESTAR,22mm,conn.

MP01559 Headgear disp.,soft farbic.sm.

MP01560 Headgaer disp.,soft fabric.la.

MP01561 Headgear disp.,soft rub.,small

MP01562 Headgear disp.,soft rub,,large

MP01916 Hookring 15mm OD

MP01917 Hookring 22mm ID

MP01708 Hook Ring for SediStar

DirectorQuality & Regulatory AffairsBusiness Unit Hospital Consumables & Accessories




Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner PiskeAnton Schrofner Page 1 / 1



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Dräger - Draeger · Rainer Klug Gert-Hartwig Lescow Dr.Reiner Piske Anton Schrofner Page 1/2. Dräger Director Quality & Regulatory Affairs Business Unit Hospital Consumables & Accessories