Taiwan FDA registration bd54964835c39c97bc865a016ae2218c

"Agility" Ophthalmic Surgical Sword (Sterile)

TW: "敏能" 眼科手術刀 (滅菌)

Taiwan·Risk Class 1·MANI INC.;; Mani Hanoi Co., Ltd. Pho Yen Factory·Registered Sep 05, 2017 – Sep 05, 2027Active

Registration details

Analysis ID: bd54964835c39c97bc865a016ae2218c
Customs Code: DHA09401826809

Company information

Manufacturer: MANI INC.;; Mani Hanoi Co., Ltd. Pho Yen Factory
Manufacturer Country: Viet Nam;;Japan
Authorized Representative: UNITED MEDICAL INC.

Product details

Intended Use: Limited to the first level identification scope of the "Manual Ophthalmic Surgical Instruments (M.4350)" of the Measures for the Classification and Grading of Medical Equipment.
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;; 委託製造

Dates and status

Registration Date: Sep 05, 2017
Expiry Date: Sep 05, 2027

About this record

Access comprehensive regulatory information for "Agility" Ophthalmic Surgical Sword (Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number bd54964835c39c97bc865a016ae2218c and manufactured by MANI INC.;; Mani Hanoi Co., Ltd. Pho Yen Factory. The authorized representative in Taiwan is UNITED MEDICAL INC..

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