Taiwan FDA registration 353ed7bda73f49ac601b3e34b47e2931

"Birutoku" manual osteologic surgical instrument (sterilization)

TW: "美瑞特" 手動式骨科手術器械 (滅菌)
Taiwan flagTaiwan·Risk Class 1·L.Z. Form Kft.;; MERIT MEDICAL SYSTEMS, INC.·Registered Mar 05, 2021 – Mar 05, 2026Expired
Registration details
Analysis ID
353ed7bda73f49ac601b3e34b47e2931
Customs Code
DHA09402235802
Company information
Manufacturer Country
United States;;Hungary
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "Manual orthopedic surgical instruments (N.4540)" first grade identification range.
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;; 輸入;; 委託製造
Dates and status
Registration Date
Mar 05, 2021
Expiry Date
Mar 05, 2026
About this record

Access comprehensive regulatory information for "Birutoku" manual osteologic surgical instrument (sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 353ed7bda73f49ac601b3e34b47e2931 and manufactured by L.Z. Form Kft.;; MERIT MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is Merit Medical Asia Company Limited Taiwan Branch (Hong Kong).

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