Taiwan FDA registration dd4dc90c5618bdf6a161b0a6e8c0a89c

“RETINA” Surgical Navigation System

TW: “雷帝納”手術導航系統及其附件

Taiwan·Risk Class 2·MD·EPED INC.·Registered Oct 24, 2017 – Oct 24, 2027Active

Registration details

Analysis ID: dd4dc90c5618bdf6a161b0a6e8c0a89c
License Form: Ministry of Health Medical Device Manufacturing No. 005918

Company information

Manufacturer: EPED INC.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: EPED INC.

Product details

Intended Use: For details, it is Chinese approved copy of the imitation order. Performance changes and new specifications: For details, please refer to the approved copy of the Chinese counterfeit order (the original 106.11.6 approved copy of the imitation order and label approval will be recycled and invalidated).
Product Type (Level 1): K Devices for neuroscience
Product Type (Level 2): K4560 Instrument for stereotaxic use in the nervous system
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: Oct 24, 2017
Expiry Date: Oct 24, 2027

About this record

Access comprehensive regulatory information for “RETINA” Surgical Navigation System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dd4dc90c5618bdf6a161b0a6e8c0a89c and manufactured by EPED INC.. The authorized representative in Taiwan is EPED INC..

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