Declaration Of Conformity; Declaração De Conformidade - IDS BLANC ONE ARCUS MOBILE Mode D'emploi

XV. DECLARATION OF CONFORMITY
DICHIARAZIONE DI CONFORMITÀ - KONFORMITÄTSERKLÄRUNG - DÉCLARATION DE CONFORMITÉ
DECLARACIÓN DE CONFORMIDAD - DECLARAÇÃO DE CONFORMIDADE
Пловдив
бул. Васил Априлов 155
office@bglight.com
Manufacturer:
Address:
Product:
Classification:
Classification is done by the manufacturer according to Medical Device Directive 93/42/EEC+AC:2007, Rule 9, Annex IX.
Notified body: TUV NORD Polska Sp. z o.o., ul.Mickiewicza 29, 40-085 Katowice, Poland.
This Declaration of conformity is valid only in combination with our certificates of Notified body TUV NORD Polska Sp. z o.o.
Certificates N: AC090 100/0951/4047/2014, AC090 MD/0951/4047/2014, TNP/MDD/0122/4047/2015..
The manufacturer declares under its sole responsibility that the products are developed and produced in conformity with MDD
93/42/EEC+AC:2007 and the following applicable standards:
EN 60601-1
EN 60601-1-2
EN 62304
EN 62353
EN 62366
EN ISO 14155-1
EN ISO 14155-2
EN ISO 14971
EN ISO 15223-1
EN 1041
EN ISO 10993-1
All company products are manufactured under the current Quality Management System, ISO 9001 and ISO 13485.
Dipl. Eng. Plamen Karaivanov
Manager
BG LIGHT LTD
07.03.2019
Plovdiv, Bulgaria
86 LED Bleaching Lamp - MOBILE
Декларация за съответствие

Declaration of conformity

BG LIGHT LTD
155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria
Tel.: +359 32 644089, Fax: +359 32 641913
BULSTAT 115841960, Tax N: 1165887138
BlancOne ARCUS Mobile
+
Active device in Class IIa of the Medical Device Directive 93/42/EEC+AC:2007
Electrical safety,
Electromagnetic compatibility
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. General requirements.
Clinical investigation of medical devices for human subjects. Clinical investigation plans.
Medical devices – Application of risk management to medical devices
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
- Part 1: General requirements
Information supplied by the manufacturer with medical devices
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
TOUCH
STICK
HOME
DAY
CARE
ТД 11
Редакция 01
Лист 1 от 1
2274
ULTRA
DUETTO
HOME
NIGHT
DUETTO
ACTIVE
CLICK
ARCUS
LIPS
ARCUS
DUETTO
CARE