Certifications; Importer Information; Directives; Classifications - GE Vivid S70 User Manual

Certifications

Importer Information

Directives

Classifications

–
Vivid S70 / S60 User Manual
BC092760-1EN 01
• Quality management standards for medical devices: GE
Medical Systems, Israel Ltd. and GE Medical Systems,
China Co. Ltd. are ISO13485 certified.
• TURKEY
Türkiye GE Medical Systems Türkiye Ltd. Şti.
İthalatçısı / Esentepe Mah. Harman Sok. No: 8
Turkish 34394 Şişli İstanbul Türkiye
Importer
• BRAZIL
Brazilian GE Healthcare do Brasil Comércio e Serviços
Importer
para Equipamentos Médico- Hospitalares Ltda
Av. Magalhães de Castro, 4800
Andar 11 Conj. 111 e 112, Andar 12 Conj. 121 e
122, Torre 3 - Cidade Jardim
São Paulo SP – CEP: 05676-120
C.N.P.J.: 00.029.372/0001-40
Número de Registro ANVISA: 80071260360
The GE ultrasound product families are tested to meet all
applicable requirements in relevant EU Directives and
European/International standards.
• Council Directive 93/42/EEC concerning MDD (Medical
Devices Directive): the CE label affixed to the product
testifies compliance to this Directive.
The location of the CE marking is specified in 'Device labels'
on page 2-26.
• Year of first CE mark: 2015
According to 93/42/EEC Medical Device Directive, this is a
Class IIa Medical Device.
The following classifications are in accordance with the IEC/
EN 60601-1:
• According to IEC/EN 60601-1, Equipment is Class I, with BF
or CF Applied Parts.
i-3