A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states.

View the "EN 1639:2009" standard description, purpose. Or download the PDF of the directive or of the official journal for free

作为一家获得医疗器械指令 (93/42/eec) 认证资质的公告机构（英国为 0120，比利时为 1639），我们资质覆盖范围广泛，可帮助您获得 ce 标志认证。 该范围覆盖大部分产品，仅有一小部分例外，如有源植入器械。

SGS is a Medical Device Notified Body for your range of products and certification will be undertaken as Notified Body 1639 for SGS Belgium NV. This means you are entitled to use CE 1639 on devices within your scope on the completion of a successful audit and technical documentation assessment.

2019年3月1日 · 有意向的客户可自愿申请转机构，将SGS UK NB 0120下的医疗器械CE证书转入NB 1639。 转机构流程即将公开，并有专门的客服人员提供针对性指导。 目前SGS在比利时及芬兰的业务持续顺利开展，公告机构SGS NB 0598和NB 1639均已在申请MDR资质，预计将于今年夏天取得授权。 其中NB 1639将扩大其授权范围与现有NB 0120一致，以此满足医疗器械及体外诊断医疗器械客户的认证需求。 随着计划的推进和政治形势的进一步明朗，SGS将提供进一步的 …

在某些医疗设备上，ce标记旁边显示的ce标记四位数数字是“公告机构（nb）”编号。如果没有ce标记的四位数数字，则表示该 医疗设备 是不需要nb介入（即自我声明）的i类设备。如果该设备是i类设备，并且ce标记旁边有一个nb号，则该设备具有测量功能或已消毒。

SGS Belgium NV Noorderlaan 87 BE-2030 Antwerpen Country : Belgium. Notified Body number : 1639

2020年5月22日 · In response to the Brexit, please be informed that since the 16th December 2019, Green DenTech’s CE notified body has been changed from SGS UK (CE0120) to SGS Belgium (CE1639). This change will NOT affect the Declarations of Conformities , but the labeling and certification.

Voluntary change of Notified Body to SGS Belgium NV includes certification as Notiied Body 1639 under European Medical Device Product Regulation (EU) 2017/745 (MDR). Class I Sterile, reusable Classification.

Conformité Européenne (CE) 认证 是一项监管标准，用于验证某些产品在欧洲经济区 (EEA) 的销售和使用安全。制造商在经过认证的产品上贴上 CE 标志，表明该产品符合欧洲安全规则，可以在 EEA 内自由交易。