Taiwan FDA registration 406b5a1c275704ea53340965835e6b31

"Mandolin" silicone filled prosthesis

TW: “曼陀”矽膠填充義乳
Taiwan flagTaiwan·Risk Class 3·MENTOR·Registered Oct 21, 2008 – Oct 21, 2028Active
Registration details
Analysis ID
406b5a1c275704ea53340965835e6b31
Customs Code
DHA00601946200
Company information
Manufacturer
MENTOR
Manufacturer Country
United States
Authorized Representative
JOHNSON & JOHNSON MEDICAL TAIWAN LTD.
Product details
Intended Use
Suitable for women for breast reconstruction surgery, which involves the first reconstruction to replace breast tissue removed due to cancer or trauma. Breast reconstruction also involves reconstructive surgery to correct or modify the results of the first breast reconstruction surgery. 102.10.2 New Performance: As detailed as Chinese Approved Copy, the original approved Chinese copy of Replica Order dated October 27, 97 and August 22, 100 is recycled and scrapped, the following blank.
Product Type (Level 1)
I General, Plastic Surgery and Dermatology
Product Type (Level 2)
I.3540 Silicone-filled breast supplements
Import Information
import
Dates and status
Registration Date
Oct 21, 2008
Expiry Date
Oct 21, 2028
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About this record

Access comprehensive regulatory information for "Mandolin" silicone filled prosthesis in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 406b5a1c275704ea53340965835e6b31 and manufactured by MENTOR. The authorized representative in Taiwan is JOHNSON & JOHNSON MEDICAL TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including MENTOR MEDICAL SYSTEMS B.V., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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