Declaration of conformity

Product catalog summary

Declaration of Conformity Overview

Manufacturer Information:
DKL CHAIRS GmbH, An der Ziegelei 3, D-37124 Rosdorf, Germany. SRN/Actor ID: DE-MF-000005032.

Medical Device Details:
The declaration covers dental units used for diagnosis and therapy in dentistry for both children and adults. These devices are classified as Class IIa under Annex VIII, Rule 9 of Regulation (EU) 2017/745.

Product List:
Includes models such as D2-SOLO, D2-SAE, D2-EC, and others, all with Basic UDI-DI: ++D064L2D2Serie28.

Regulatory Compliance:
The devices comply with the Medical Device Regulation (MDR) (EU) 2017/745 and meet all applicable requirements. Harmonized standards such as ISO 13485, IEC 62304, IEC 62366, ISO 14971, IEC 60601-1, and others are fulfilled.

Conformity Assessment Procedure:
Conducted according to Regulation (EU) 2017/745 (MDR), Annex IX. The notified body involved is TÜV SÜD Product Service GmbH, Munich, with certificate No. G10 027377 0020 Rev. 00.

Essential Safety and Performance:
The devices meet the essential safety and performance requirements as per Annex I of Regulation (EU) 2017/745.

Validity:
The declaration is valid from the date of signature, which is 16.05.2023, signed by the CEO.

Catalog excerpts

Konformitätserklärung/ Declaration of conformity Name und Adresse des Herstellers Name and address of the manufacturer SRN/Actor ID DKL CHAIRS GmbH An der Ziegelei 3 D-37124 Rosdorf Deutschland DE-MF-000005032 Wir erklären in alleiniger Verantwortung, dass die nachfolgend gelisteten Medizinprodukte/We declare under our sole responsibility that the medical device listed below Diese Behandlungseinheit dient zur Diagnose und Therapie von Kindern und Erwachsenen im zahnmedizinischen Bereich./This treatment unit is used for the diagnosis and therapy of children and adults in the fi eld of dentistry. Basis UDI-DI/Basic UDI-DI ++D064L2D2Serie28 nach Anhang VIII, Regel 9 der Verordnung (EU)2017/ 745/according to annex VIII, rule 9 of regulation (EU) 2017/745

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Medizinprodukte im Sinne von Artikel 2 (1) der (EU)2017/745 für Medizinprodukte (MDR) sind/ are medical devices according to article 2 (1) of the Medical Device Regulation (MDR) (EU)2017/745 und allen Anforderungen der Verordnung nach Anhang IX (EU)2017/745 für Medizinprodukte (MDR) entsprechen, die anwendbar sind/and comply with all requirements of the Medical Device Regulation (MDR) Annex IX (EU)2017/745 that are applicable. Angewandte harmonisierte Normen, nationale Normen oder andere normative Dokumente werden erfüllt./Applied harmonised standards, national standards or other normative documents...

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Festlegungen an die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von DentalGeräten/ Medical Electrical Equipment - Part 260: Particular requirements for the basic safety and essential performance of dental equipment DIN EN ISO 7494-1: Zahnheilkunde - Fest installierte dentale Behandlungseinheiten und dentale Patientenliegen - Teil 1: Allgemeine Anforderungen/ Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements DIN EN ISO 7494-2: Zahnheilkunde – Zahnärztliche Behandlungseinheiten – Teil 2: Luft-, Wasser-, Absaugungs- und Abwassersysteme/...

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Declaration of conformity

Declaration of conformity

Catalog excerpts

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