---
title: "Orient Biotech has obtained the medical device registration certificate"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/247269015.md"
description: "Orient Biotech announced that some clients of the company and its subsidiary, American Hengjian Biotechnology Co., Ltd., recently obtained overseas medical device registration certificates or production and sales licenses for several respiratory combination detection products. At the same time, the holding subsidiary Beijing Xinxing Sihuan Biotechnology Co., Ltd. completed a product change registration. This move will help expand domestic and international markets"
datetime: "2025-07-04T08:39:03.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/247269015.md)
  - [en](https://longbridge.com/en/news/247269015.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/247269015.md)
---

# Orient Biotech has obtained the medical device registration certificate

According to the Zhitong Finance APP, Orient Biotech (688298.SH) announced that the company and its subsidiary, American Hengjian Biotechnology Co., Ltd., have recently obtained overseas medical device registration certificates or production and sales licenses for several respiratory combined detection products from some cooperative clients; the holding subsidiary Beijing Xinxing Sihuan Biotechnology Co., Ltd. has completed a change registration (filing) for one product.

The company's respiratory antigen combined detection reagents (self-test/professional) have been registered in the aforementioned countries and regions, indicating that these products meet the requirements of the relevant countries and regions and have obtained market access conditions. The Class III registration certificate change for the Helicobacter pylori antigen detection reagent mainly adds self-testing purposes and extends the product's validity period, further increasing the range of potential customers based on existing sales. The certification/registration changes for the above products are beneficial for the overall expansion of domestic and international markets

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