Taiwan FDA registration a32e0a269e4694709f184f5edf086e5b

“Bioptigen” Envisu Spectral Domain Ophthalmic Imaging System

TW: “拜歐爵”鷹范視光學同調斷層掃描系統
Taiwan flagTaiwan·Risk Class 2·MD·Leica Microsystems NC, Inc.·Registered Nov 20, 2018 – Nov 20, 2023Expired
Registration details
Analysis ID
a32e0a269e4694709f184f5edf086e5b
License Form
Ministry of Health Medical Device Import No. 031849
Customs Code
DHA05603184902
Company information
Manufacturer Country
United States
Authorized Representative
CHIU HO SCIENTIFIC CO., LTD.
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
M Ophthalmic devices
Product Type (Level 2)
M1570 fundus mirror
Import Information
Imported from abroad
Dates and status
Registration Date
Nov 20, 2018
Expiry Date
Nov 20, 2023
About this record

Access comprehensive regulatory information for “Bioptigen” Envisu Spectral Domain Ophthalmic Imaging System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a32e0a269e4694709f184f5edf086e5b and manufactured by Leica Microsystems NC, Inc.. The authorized representative in Taiwan is CHIU HO SCIENTIFIC CO., LTD..

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