# China NMPA Product Recall - EB-1600MD Semiconductor Laser Therapy Machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-medbe-laser-technology-co-ltd/0bb58add-4819-46b2-977b-6f3fb5996a9e/
Source feed: China

> China NMPA product recall for EB-1600MD Semiconductor Laser Therapy Machine by Shanghai Medbe Laser Technology Co., Ltd. published February 24, 2021. Recall level: Level 3 Recall. Shanghai Yibei Laser Technology Co., Ltd. initiated a voluntary Class III recall for its EB-1600MD s

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Yibei Laser Technology Co., Ltd. voluntarily recalls semiconductor laser therapy machines.
- Company Name: Shanghai Medbe Laser Technology Co., Ltd.
- Publication Date: 2021-02-24
- Product Name: EB-1600MD Semiconductor Laser Therapy Machine
- Recall Level: Level 3 Recall
- Recall Reason: Because the product in question was subject to a new national medical device classification catalog implemented on August 1, 2018, the company's registration certificate number for this product changed after its renewal registration was completed in 2020. Before the change was completed in the product registration form, the company used the renewal registration certificate number for production and sales. Therefore, the company has decided to voluntarily recall the EB-1600MD semiconductor laser therapy machine that was manufactured and sold beyond its expiration date in February 2021. This recall does not involve product defects or safety issues and will not pose any risks.
- Discovering Company: Shanghai Medbe Laser Technology Co., Ltd.
- Manufacturing Company: Shanghai Medbe Laser Technology Co., Ltd.
- Summary: Shanghai Yibei Laser Technology Co., Ltd. initiated a voluntary Class III recall for its EB-1600MD semiconductor laser therapy machine, as announced by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration on February 24, 2021. This action addresses a procedural discrepancy rather than a product defect or safety concern. The issue arose because the company utilized a new registration certificate number for production and sales prematurely. Following the renewal of the product's registration in 2020, necessitated by a new national medical device classification catalog implemented in August 2018, the company began using the updated certificate number before its official recordation was finalized in the product registration form. The recall specifically targets machines manufactured and sold after the previous registration certificate's expiration in February 2021. Shanghai Yibei Laser Technology Co., Ltd. clarified that this recall does not involve product defects or pose any safety risks, with detailed affected product information available in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/shanghai-medbe-laser-technology-co-ltd/6c4718ec-c0ee-4298-9d7b-90a1400e7f90/