1. 行政信息Administration Information |
接受者（国家主管当局名称）Recipient (Name of National Competent Authority NCA) 新年歌曲 | ||
国家主管当局地址Address of National Competent Authority | ||
报告日期Date of this report | ||
制造商指定的参考号码Reference number assigned by the manufacturer | ||
国家主管当局指定的接收者索引号码Reference number assigned by NCA | ||
报告类型Type of report 趋势初始Trend Initial 趋势跟踪Trend Follow up 趋势最终Trend Final | ||
事件是否构成严重危害公众健康Do the incidents / trend reprent a rious public health threat? 是Yes 否No | ||
确定该报告的其他发送国家主管当局Identify to what other NCAs this report was also nt | ||
2. 报告提交人信息Information on submitter of the report | ||
发送人身份Status of submitter 制造商Manufacturer EEA ,瑞士和土耳其内授权代表Authorid Reprentative within EEA, Switzerland and Turkey 其他（请表明其身份）Others: (identify the role) : | ||
3.制造商信息 Manufacturer information | ||
制造商名称Name | ||
联系人姓名Contact name | ||
地址Address | ||
邮编Postcode | 城市City | |
电话Phone | 传真Fax | |
E-mail | 国家Country | |
4. 授权代表信息Authorid Reprentative information | ||
授权代表名称Name | ||
授权代表联系人Contact name | ||
地址Address | ||
邮编Postcode | 城市City | |
电话Phone | 传真Fax | |
E-mail | 国家Country | |
5. 报告提交者信息（如果不同于第3、4节）Submitter’s information (if different from ction 3 or 4) | ||
提交者姓名Submitter’s name | ||
联系人姓名Contact name | ||
地址Address | ||
邮编Postcode | 城市City | |
电话Phone | 传真梁鸣海战Fax | |
E-mail | 国家Country | |
6. 医疗器械信息Medical Device Information |
分类Class □ 有源植入类AIMD Active implants □ MDD法规规定第III类 MDD Class Ш □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A □ MDD法规规定第Ⅱb类 MDD Class Ⅱb □ IVD 附件Ⅱ列表B IVD AnnexⅡ List B □ MDD分类 Ⅱa MDD Class Ⅱa □ IVD自测诊断器械 IVD Devices for lf-testing □MDD分类 MDD ClassⅠ □ IVD一般 IVDGeneral | |||
分类系统(最好是GMDN) Nomenclature system (preferable GMDN) | 分类系统代号Nomenclature code | ||
分类内容Nomenclature text | |||
商品名/品牌名/制造者Commercial name/ brand name / make | |||
型号或者姓Model number(s) or Family name | 编号幼儿个案观察记录表大班Catalogue number(s) | ||
序列(适用时)号Serial number range (if applicable) | 批号Lot/batch number range(if applicable) | ||
软件版本号(适用时) Software version number (if applicable) | |||
附件/水草养殖随附器械(适用时) Accessories / associated devices (if applicable) 高中数学怎么学才能学好 | |||
公告机构识别号码Notified Body (NB) ID – Number | |||
7.趋势报告信息Information on Trend Report | |||
确定趋势日期Date the trend was identified | |||
描述称述的确定趋势Description narrative for identified trend | |||
趋势分析时间段Time period of trend analysis | |||
建立调节触发Established trigger level | |||
是否在警戒情况下作为可报告的事件单独递交？Have any of the trended events been submitted individually as reportable events under vigilance? 是Yes 否No | |||
如果是，请列出数量和提交给了哪些国家主管部门If yes, plea list how many and to which Competent Authority | |||
8. 制造商的初步意见Manufacturer’s preliminary comments | |||
桂林山水图片制造商对趋势事件的初步分析Manufacturer’s preliminary analysis into caus of trend | |||
制造商最初的纠正/预防措施的实施情况Initial corrective actions / preventive actions implemented by the manufacturer | |||
预期下一个报告的时间Expected date of next report | |||
9. 制造商的最终调查趋势的结果Results of manufacturer’s final investigation into trend | |||
制造商趋势分析结果The manufacturer’s trend analysis results | |||
补救措施/纠正/预防措施/现场安全纠正措施Remedial action / corrective action / preventive action / Field Safety Corrective Action | |||
确定行动实施的时间计划Time scheduled for the implementation of the identified actions | |||
制造商最后评价Final comments from the manufacturer | |||
未来的调查Further investigation | |||
10. 医疗器械被经销至以下国家The medical device has been distributed to the following Countries | |||
在EEA,瑞士和土耳其内Within EEA, Switzerland and Turkey: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK TR 候选国家Candidate Countries: HR 所有EEA-, 候补国家和瑞士All EEA, Candidate Countries, Switzerland and Turkey 其他Others: | |||
11. 评价Comments |
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