Vietnam MOH registration 2403347ĐKLH/BYT-HTTB

Biological Hydroxyapatite Bone Substitute

VN: Xương nhân tạo sinh học

ExcelOS Inject

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·CG Bio Co., Ltd.·Registered Nov 06, 2024

Registration details

Analysis ID: 2403347ĐKLH/BYT-HTTB
Submission ID: 18007320/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: CG Bio Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: CG Bio Co., Ltd.
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN DAEWOONG PHARMACEUTICAL CO., LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: The product is intended for the treatment of bone defects or bone deficiencies that are not related to the stability of the bone structure. ExcelOS Inject is indicated to fill bone defects and cavities of the skeletal system (such as the bones of the limbs, the spine, and the pelvis), and to fill and/or augment bone deficiencies in the mouth/mandible. The product provides a bone graft material that is capable of reabsorption and is replaced by bone during the healing process.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Biological Hydroxyapatite Bone Substitute in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403347ĐKLH/BYT-HTTB and manufactured by CG Bio Co., Ltd.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN DAEWOONG PHARMACEUTICAL CO., LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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