Taiwan FDA registration 18515d4e5c604a59c8ee5ef73162d69a
“Optopol”REVO Optical Coherence Tomography
TW: “歐圖博”眼科光學斷層掃描儀
Taiwan·Risk Class 2·MD·OPTOPOL TECHNOLOGY SP. Z O.O. ·Registered Aug 31, 2022 – Aug 31, 2027ActiveRegistration details
- Analysis ID
- 18515d4e5c604a59c8ee5ef73162d69a
- License Form
- Ministry of Health Medical Device Import No. 035776
- Customs Code
- DHA05603577605
Company information
- Manufacturer
- OPTOPOL TECHNOLOGY SP. Z O.O.
- Manufacturer Country
- Poland
- Authorized Representative
- BIOMEGA INSTRUMENT CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- M Ophthalmology
- Product Type (Level 2)
- M1570 fundus mirror
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 31, 2022
- Expiry Date
- Aug 31, 2027
About this record
Access comprehensive regulatory information for “Optopol”REVO Optical Coherence Tomography in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 18515d4e5c604a59c8ee5ef73162d69a and manufactured by OPTOPOL TECHNOLOGY SP. Z O.O. . The authorized representative in Taiwan is BIOMEGA INSTRUMENT CO., LTD..
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