Taiwan FDA registration c76897ee82640b40803e5053c90fdbcf
"Nidek" ophthalmic refractometer(Non-Sterile)
TW: "尼德克" 眼科驗光機(未滅菌)
Taiwan·Risk Class 1·MD·NIDEK CO., LTD. HAMACHO PLANT·Registered Oct 01, 2021 – Oct 31, 2026ActiveRegistration details
- Analysis ID
- c76897ee82640b40803e5053c90fdbcf
- License Form
- Ministry of Health Medical Device Import Registration No. 009979
- Customs Code
- DHA08400997906
Company information
- Manufacturer
- NIDEK CO., LTD. HAMACHO PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- IKI MEDICAL CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of ophthalmic optometry machine (M.1760) of the management measures for medical equipment.
- Product Type (Level 1)
- M Ophthalmic devices
- Product Type (Level 2)
- M1760 Ophthalmic Refractive Machine
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 01, 2021
- Expiry Date
- Oct 31, 2026
About this record
Access comprehensive regulatory information for "Nidek" ophthalmic refractometer(Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number c76897ee82640b40803e5053c90fdbcf and manufactured by NIDEK CO., LTD. HAMACHO PLANT. The authorized representative in Taiwan is IKI MEDICAL CO., LTD..
This page provides complete technical specifications, regulatory compliance details. 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.
Free DatabasePowered by Pure Global AI89,000+ Devices