Taiwan FDA registration cf6045aff6aca4f33362c8a9a1a3f58e

"Acdel" Manual Eye Surgery Instruments (Sterilized)

TW: "愛可德" 手動式眼科手術器械 (滅菌)

Taiwan·Risk Class 1·ACCUTOME, INC.·Registered Apr 22, 2016 – Apr 22, 2021Cancelled

Registration details

Analysis ID: cf6045aff6aca4f33362c8a9a1a3f58e
Customs Code: DHA09401643900

Company information

Manufacturer: ACCUTOME, INC.
Manufacturer Country: United States
Authorized Representative: BIOMEGA INSTRUMENT CO., LTD.

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Manual Eye Surgery Instruments (M.4350)".
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.4350 手動式眼科手術器械
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Apr 22, 2016
Expiry Date: Apr 22, 2021
Cancellation Date: Aug 15, 2023

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Acdel" Manual Eye Surgery Instruments (Sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number cf6045aff6aca4f33362c8a9a1a3f58e and manufactured by ACCUTOME, INC.. The authorized representative in Taiwan is BIOMEGA INSTRUMENT CO., LTD..

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