Taiwan FDA registration 3800c6e53e607bea596098e90627ef46

"En Avan" otoscopy (unsterilized)

TW: "恩艾萬" 耳鏡 (未滅菌)

Taiwan·Risk Class 1·M.I.ONE CO.,LTD·Registered Dec 18, 2019 – Dec 18, 2029Active

Registration details

Analysis ID: 3800c6e53e607bea596098e90627ef46
Customs Code: DHA09402111102

Company information

Manufacturer: M.I.ONE CO.,LTD
Manufacturer Country: Korea, Republic of
Authorized Representative: WHOLE WELL CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the "Otoscope (G.4770)" of the Administrative Measures for the Classification and Grading of Medical Equipment.
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.4770 Ear Mirrors
Import Information: import

Dates and status

Registration Date: Dec 18, 2019
Expiry Date: Dec 18, 2029

About this record

Access comprehensive regulatory information for "En Avan" otoscopy (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3800c6e53e607bea596098e90627ef46 and manufactured by M.I.ONE CO.,LTD. The authorized representative in Taiwan is WHOLE WELL CO., LTD..

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