Declaration Of Conformity - Blancone ARCUS+ Instrucciones De Uso

GB
XV. DECLARATION OF CONFORMITY
TECHNICAL FILE
BLANCONE ARCUS+
LED bleaching activation unit
Manufacturer:
SRN:
Address:
Product:
Dental LED bleaching
activation unit
Basic UDI:
EMDN code:
Classification:
Intended purpose: BLANCONE ARCUS+ is designed to bleach the solid tooth tissue by photoactivation (irradiation of blue light
430-490 nm) of dental bleaching gel. BLANCONE ARCUS+ is accessory for a medical device as described in article 2, p.(2) as it
performs its intended purpose together with dental bleaching gel.
The manufacturer declares under its own responsibility that the specified medical device complies with the applicable GENERAL
SAFETY AND PERFORMANCE REQUIREMENTS, defined in Annex I of the normative act described below and normative
technical documents, when used for its intended purpose and in accordance with the safety requirements.
Document
Regulation
(EU)
2017/745
To achieve compliance, the requirements of the following standards are met:
EN ISO 13485:2016 +/AC:2017/
/AC:2018/ A11:2022 +/AC:2017/
/AC:2018/ A11:2022
EN ISO 9001:2015
ЕN ISO 60601-1:2006
/A1:2013/AC:2014/A2:2022
EN 60601-1-2:2015/A1:2021
EN 60601-1-6:2010+ /A1:2015 /
/A2:2021
EN 60601-1-8:2007+ /A1:2013
/A11:2017 /A2:2021
EN ISO 10650:2018
EN 62304:2006/А1:2015
EN 62353:2014
EN 62366-1:2015+ AC:2016/
A1:2020
EN ISO 14155:2020
EN ISO 10993-1:2018
EN ISO 14971:2019+/A11:2022
CEN ISO/TR 24971:2020
EN ISO 15223-1:2021
EN ISO 20417:2021
Directive 2012/19/EC
Classification is done by the manufacturer according to Regulation on medical devices - MDR (EU) 2017/745, Annex VIII, Rule 13.
Conformity assessment procedure according to article 52, paragraph 7 of MDR (EU) 2017/745.
The declaration of conformity is issued in implementation of Annex IV "EU Declaration of conformity" of EU Regulation 2017/745,
based on the results of tests carried out and assessment of compliance with the General safety and performance requirements
defined in Annex I, implemented and certified Quality Management System - certificates No: AC090 100/1971/4047/2020, AC090
MD/1971/4047/2020 from TUV NORD Polska Sp. z o.o. (NB 2274).
BG LIGHT LTD maintains data on the provision, evaluation and maintenance of compliance of the medical device, according to
the requirements of Annex II "Technical documentation" of MDR (EU) 2017/745.
Plovdiv, Bulgaria
01.01.2023
18
Dental LED bleaching activation unit - MOBILE
EU Declaration of conformity
Developed in conformity with MDR (EU) 2017/745
BG LIGHT LTD
BG-MF-000019812
155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria
Tel.: +359 32 644089, +359 888 809256, email: [email protected]
BULSTAT UIC 115841960, VAT N: BG115841960
Product code:
600-001+
3800501374600000XK
Q0190
Active invasive device (accessory for medical device) of Class I of the Regulation on medical devices -
MDR (EU) 2017/745
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC
Medical devices - Quality management systems - Requirements for regulatory purposes
Quality management systems - Requirements
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
Medical electrical equipment — Part 1-8: General requirements for basic safety and essential
performance — Collateral standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
Dentistry - Powered polymerization activators
Medical device software. Software life cycle processes.
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
Medical devices. Application of usability engineering to medical devices.
Clinical investigation of medical devices for human subjects - Good clinical practice
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management
process
Medical devices – Application of risk management to medical devices.
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Medical devices - Symbols to be used with information to be supplied by the manufacturer –
Part 1: General requirements
Medical devices - Information to be supplied by the manufacturer
Directive on waste electrical and electronic equipment (WEEE)
Dipl. Eng. Plamen Karaivanov
Manager
BG LIGHT LTD
Name:
BLANCONE ARCUS+ (mobile)
Title
and 93/42/EEC
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