Taiwan FDA registration 8352bbc831bc483fbd0ac255200da0d6

"Yisheng Lachirosi" Intervertebral Assisted Stabilization Implant Surgical Instrument (Non-sterilized)

TW: "醫晟拉脊斯" 椎間輔助穩定植入物手術器械 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Heli Biotech Co., Ltd.;; Medical Sheng Co., Ltd·Registered May 29, 2024 – May 29, 2029Active
Registration details
Analysis ID
8352bbc831bc483fbd0ac255200da0d6
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
ESSENCE MEDICAL DEVICES CO., LTD.
Product details
Intended Use
It is limited to the first level of identification scope of manual orthopedic surgical instruments (N.4540) in the management measures for the classification and grading of medical devices.
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N.4540 手動式骨科手術器械
Import Information
QMS/QSD;; 委託製造;; 國產
Dates and status
Registration Date
May 29, 2024
Expiry Date
May 29, 2029
About this record

Access comprehensive regulatory information for "Yisheng Lachirosi" Intervertebral Assisted Stabilization Implant Surgical Instrument (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8352bbc831bc483fbd0ac255200da0d6 and manufactured by Heli Biotech Co., Ltd.;; Medical Sheng Co., Ltd. The authorized representative in Taiwan is ESSENCE MEDICAL DEVICES CO., LTD..

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