[Asia Economy Reporter Hyunseok Yoo] NeoFect, a specialized company in innovative medical solutions, announced on the 24th that its subsidiary Weber Instrument has obtained the European CE certification for the complex pain treatment device ‘Zeus Wave’.
With this CE certification, Weber Instrument can now supply the ‘Zeus Wave’ to the European market. Utilizing NeoFect’s German branch’s European sales network, full-scale sales are scheduled to begin early next year.
‘Zeus Wave’ is a non-surgical treatment device that simultaneously implements piezo-type focused treatment technology and pneumatic-type radial treatment technology among extracorporeal shock wave therapy (ESWT) technologies. In Korea, it is used in orthopedics, rehabilitation medicine, and anesthesiology for treating acute and chronic musculoskeletal pain such as shoulder, elbow, and knee pain, and it is also applicable in sports rehabilitation and aesthetic fields.
Notably, it is the first domestically developed extracorporeal shock wave therapy device using multi-array piezo-type technology, offering high accuracy in focusing and stable output. By adopting piezo elements in a multi-array configuration in the piezo handpiece, it allows free adjustment of focus size and penetration depth. This enables precise and delicate control of the lesion area, enhancing treatment effectiveness.
A NeoFect official stated, “Weber Instrument’s Zeus Wave has already been delivered to over 800 hospitals and clinics domestically and has been verified for treatment satisfaction by many users. Receiving CE certification, which requires meeting high-level standards, not only externally recognizes the product’s quality but also opens up possibilities for overseas market expansion, making this achievement very significant.”
He added, “Now that we can start exporting not only domestically but also to overseas markets, we expect a significant growth in performance next year based on NeoFect’s European sales channels.”
Weber Instrument recently also obtained ISO13485 (2016) certification, an international quality management system standard for medical devices. Starting with the European market entry, they plan to expand overseas sales channels to countries that require ISO certification, such as India, the Middle East, and Southeast Asia. Preparations for obtaining approval within China through a joint venture are also progressing rapidly.
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