Vietnam MOH registration 2403087ĐKLH/BYT-HTTB

Artificial Hip Joint

VN: Bộ khớp háng nhân tạo
Vietnam flagVietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Surgival Co, S.A.U·Registered Nov 02, 2024
Registration details
Analysis ID
2403087ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-230316-0016
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer
Surgival Co, S.A.U
Manufacturer Country
Theo theo phụ lục
Product Owner
Surgival Co, S.A.U
Technical details
Intended Use
This product allows for the total or partial replacement of the hip joint, thus restoring the proper function of the hip joint, which means transferring the load and the mechanical energy of the patient's activity, between the pelvis and the femur. It enables the patient to perform normal physical activities without pain or discomfort. Therefore, it is an invasive product, meaning it requires surgical intervention to be implanted into the patient's body, and it is a single-use product, not intended for re-use. Consequently, it can be considered both in the sense of "not intended for use on multiple patients" and in the sense of "not intended for re-use on the same patient". The risks associated with re-use of this product include the potential damage to the implanted component due to fatigue, leading to the need for further surgery, and the risk of infection transmission due to cross-contamination (virus, prion, etc.).
Dates and status
Registration Date
Nov 02, 2024
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About this record

Access comprehensive regulatory information for Artificial Hip Joint in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403087ĐKLH/BYT-HTTB and manufactured by Surgival Co, S.A.U. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ N.T.K.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Sanatmetal Orthopaedic & Traumatologic Equipment Manufacturer Ltd., Theo phụ lục, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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