MANUFACTURER’S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
FULL QUALITY ASSURANCE PROCEDURE
This is a declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian
Therapeutic Goods (Medical Devices) Regulations 2002 relating to the stated devices
GMDN Code and Term:
Scope of Application: Each medical device complies with the applicable provisions of the essential principles and the classification rules under Council Directive 93/42/EEC Annex V

Each kind of medical device to which the Full Quality Assurance Procedures have been applied complies with the
applicable provisions of the essential principles, the classification rules, at each stage, from the design of the device
until its final inspection before being supplied.

Full Quality Management System Certificate: Societe Nationale de Certification et D’Homologation S.A.R.L. [0499] certificate number: L0644048-01

Design Examination Certificate:

Standards Applied:
ISO 9001:2000 & ISO 13485:2003 for the Design, Development, Production, Sales and Service to Ultrasonic Scalers with Certificate number: 21471 issued on 22/9/2006, reissued on 22/1/2007 and valid until 22/9/2009

制造商的符合标准声明
澳大利亚治疗物品（医疗器械）规例2002年
全面质量保证程序
这是一个发表的声明在按照要求，第1.8附表3澳大利亚
治疗性物品（医疗器械）规例2002年有关声明的装置
gmdn代码和任期：
适用范围：各医疗设备符合适用的规定，基本原则和分类规则下的理事会指令93/42/eec附件V

每个种医疗器械，这充分的品质保证程序已应用于符合
适用规定的基本原则，分类规则，在每一个阶段，从装置的设计
直到其最后的检验，然后才供应。

全面质量管理体系认证证书： （ Societe全国认证等-认证有限公司[ 0499 ]证书编号： l0644048 - 01

设计考试证书：

适用的标准：
通过ISO 9001:2000 ＆的ISO 13485:2003为设计，开发，生产，销售和服务，以超声波变换器与证书编号： 21471发出关于22/9/2006 ，重新印发22/1/2007和有效，直至22 / 9 / 2009年
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