Taiwan FDA registration 5fc290c4caf1f260b157dd51df3df29f

"Romex" Manual Ophthalmic Surgical Instruments (Sterilized/Non-Sterile)

TW: "羅美思" 手動式眼科手術器械 (滅菌/未滅菌)
Taiwan flagTaiwan·Risk Class 1·Rumex International Ltd;; Rumex International Co·Registered Jun 05, 2024 – Jun 05, 2029Active
Registration details
Analysis ID
5fc290c4caf1f260b157dd51df3df29f
Customs Code
DHA09402350201
Company information
Manufacturer Country
United Kingdom;;United States
Authorized Representative
BIOMEGA INSTRUMENT CO., LTD.
Product details
Intended Use
It is limited to the first level of identification of the "Manual Ophthalmic Surgical Instruments (M.4350)" of the Administrative Measures for the Classification and Grading of Medical Devices.
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
Jun 05, 2024
Expiry Date
Jun 05, 2029
About this record

Access comprehensive regulatory information for "Romex" Manual Ophthalmic Surgical Instruments (Sterilized/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 5fc290c4caf1f260b157dd51df3df29f and manufactured by Rumex International Ltd;; Rumex International Co. The authorized representative in Taiwan is BIOMEGA INSTRUMENT CO., LTD..

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