Taiwan FDA registration a3439a398eaf3e084e4ab790f30c613d

"Nidek" desktop refractive system (unsterilized)

TW: "尼德克"桌上型屈光系統(未滅菌)

Taiwan·Risk Class 1·NIDEK CO., LTD., HAMACHO PLANT·Registered Oct 01, 2021 – Oct 31, 2025Expired

Registration details

Analysis ID: a3439a398eaf3e084e4ab790f30c613d
Customs Code: DHA08401840102

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 identification scope of the "Automatic Ophthalmic Refractive Machine (M.1760)" of the Measures for the Classification and Grading of Medical Equipment.
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.1760 Automatic Ophthalmic Optical Machine
Import Information: import

Dates and status

Registration Date: Oct 01, 2021
Expiry Date: Oct 31, 2025

About this record

Access comprehensive regulatory information for "Nidek" desktop refractive system (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number a3439a398eaf3e084e4ab790f30c613d and manufactured by NIDEK CO., LTD., HAMACHO PLANT. The authorized representative in Taiwan is IKI MEDICAL CO., LTD..

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