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A Buyer’s Guide to Verifying Medical Device CE Certificates

Three Practical Steps to Avoid Compliance Risks Before You Place an Order

Many buyers trust CE certificates when sourcing medical devices from China.

But here’s the uncomfortable truth:

👉 Not all CE certificates are real or valid.

After 20 years in the medical equipment industry, I’ve seen too many cases where:

  • The certificate belongs to a different product
  • The notified body doesn’t exist or isn’t authorized
  • The certification scope doesn’t match the device

This is especially common in oxygen concentrators and respiratory devices.

So how can you protect yourself?

以下是3个快速检查方法:

1️⃣ 在欧盟官方数据库中审核公告机构编号

2️⃣确保产品型号完全匹配

3️⃣ 要求提供完整的技术文档,而不仅仅是 PDF 证书

如果供应商已经回避了这些问题,那答案就很明显了。

边境医疗采购风险不仅是价格问题,更是控制问题。

如果您对某个供应商有任何疑问,请随时联系我。我很乐意帮助您快速查看一下。

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