Taiwan FDA registration e0fbefeea2ce22cd1c164a536bae01fa
“Bioptigen” EnFocus Optical Coherence Tomography System
TW: “拜歐爵”鷹福視光學同調斷層掃描系統
Taiwan·Risk Class 2·MD·Leica Microsystems NC, Inc.·Registered Jul 03, 2018 – Jul 03, 2028ActiveRegistration details
- Analysis ID
- e0fbefeea2ce22cd1c164a536bae01fa
- License Form
- Ministry of Health Medical Device Import No. 031206
- Customs Code
- DHA05603120609
Company information
- Manufacturer
- Leica Microsystems NC, Inc.
- 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
- Jul 03, 2018
- Expiry Date
- Jul 03, 2028
About this record
Access comprehensive regulatory information for “Bioptigen” EnFocus Optical Coherence Tomography System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e0fbefeea2ce22cd1c164a536bae01fa and manufactured by Leica Microsystems NC, Inc.. The authorized representative in Taiwan is CHIU HO SCIENTIFIC CO., LTD..
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