Taiwan FDA registration 4bd36501540f09b3a928dfc7e545c3b8

AIKEN Manual osteologic surgical instrument (unsterilized)

TW: 藍研 手動式骨科手術器械 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Lanyan Precision Co., Ltd.;; Industrial Technology Research Institute biomedical material products manufacturing plant·Registered Oct 20, 2022 – Oct 20, 2027Active
Registration details
Analysis ID
4bd36501540f09b3a928dfc7e545c3b8
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
Lanyan Precision Co., Ltd
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
國產;; 委託製造;; QMS/QSD
Dates and status
Registration Date
Oct 20, 2022
Expiry Date
Oct 20, 2027
About this record

Access comprehensive regulatory information for AIKEN Manual osteologic surgical instrument (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 4bd36501540f09b3a928dfc7e545c3b8 and manufactured by Lanyan Precision Co., Ltd.;; Industrial Technology Research Institute biomedical material products manufacturing plant. The authorized representative in Taiwan is Lanyan Precision Co., Ltd.

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