Publicité
Introduction
1
Normes appliquées
Pays
Argentina
Australia
Brazil
Brazil
Canada
China
EU
Japan
South Korea
South Korea
South Korea
Switzerland
Taiwan
UK
USA
USA
Tab. 6 :
Conformité aux normes relatives au marché
Autres informations (pour République Populaire de Chine uniquement)
产品名称：手术无影灯
规格型号：STANDOP VOLISTA 600, STANDOP VOLISTA 400
SN 序列号：见英文标签 生产日期：见英文标签
使用期限：10 年
注册证号：国械注进 20142015956
产品技术要求编号：国械注进 20142015956
注册人/生产企业名称：Maquet SAS 迈柯唯股份有限公司
注册人/生产企业住所：Parc de Limère Avenue de la Pomme de Pin CS 10008 Ardon 45074 Orléans
Cedex 2- FRANCE
生产地址：Parc de Limère Avenue de la Pomme de Pin CS 10008 Ardon 45074 Orléans Cedex 2-
26 / 108
Référence
Année
Dispocision
2002
2318/2002
TGA 236-2002
2019
RDC 665/2022
2022
RDC 185/2001
2001
SOR/98-282
2021
Regulation n°739
2021
Regulation
2017
2017/745/EU
MHLW Ordi-
2021
nance: MO n°169
Act 14330
2016
Decree 27209
2016
Rule 1354
2017
RS (Odim)
2020
812.213
TPAA
2018
2018-01-31
Act
2021
21CFR Part 7
2017
21CFR Subchap-
ter H
Intitulé
Administración Nacional de Medicamentos, Ali-
mentos y Tecnología Médica - Registro de pro-
ductos Medicas - Reglamento
Therapeutic Goods (Medical Devices) Regula-
tions 2002. Statutory Rules No. 236, 2002 made
under the Therapeutic Goods Act 1989
GMP Requirements for Medical Devices and IVDs
Technical regulation about the registration of me-
dical products at ANVISA, as well as its alteration,
revalidation, or cancellation
Medical Devices Regulations
Regulation for the Supervision and Administration
of Medical Devices
Medical Devices Regulations
Ministerial Ordinance on Standards for Manufac-
turing Control and Quality Control for Medical De-
vices and In-Vitro Diagnostics
Medica Device Act
Enforcement Decree of Medicl Act
Enforcement Rule of the Medical Act
Medical Devices Ordinance (MedDO) of 1 July
2020
Taiwanese Pharmaceutical Affairs Act
Medical Devices Regulations 2002 n°618
Title 21--Food And Drugs
Chapter I--Food And Drug Administration Depart-
ment Of Health And Human Services
Subchapter A -- General
PART 7 - Enforcement policy
-
Title 21--Food And Drugs
Chapter I--Food And Drug Administration Depart-
ment Of Health And Human Services
Subchapter H -- Medical Devices
VOLISTA
IFU 01781 FR 19
Publicité
