Taiwan FDA registration b69bdbf3c1724981a65a36facc94b950
"DETEKT" Cranioplasty Material Forming Module (Non-Sterile)
TW: "德芮達"頭顱造型術材料形成模具(未滅菌)
Registration details
- Analysis ID
- b69bdbf3c1724981a65a36facc94b950
- License Form
- Ministry of Health Medical Device Manufacturing No. 007278
Company information
- Manufacturer
- DETEKT TECHNOLOGY INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- DETEKT TECHNOLOGY INC.
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Material Formation Tools for Craniomodeling (K.4500)".
- Product Type (Level 1)
- K Devices for neuroscience
- Product Type (Level 2)
- K4500 Material formation tool for cranial modeling
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- May 29, 2018
- Expiry Date
- May 29, 2023
About this record
Access comprehensive regulatory information for "DETEKT" Cranioplasty Material Forming Module (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b69bdbf3c1724981a65a36facc94b950 and manufactured by DETEKT TECHNOLOGY INC.. The authorized representative in Taiwan is DETEKT TECHNOLOGY INC..
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