Taiwan FDA registration fdabc2ff512c3190b0202bf5eb9f1bc8

"Vortex" Manual Ophthalmic Surgical Instrument (Non-Sterile)

TW: "渦流" 手動式眼科手術器械 (未滅菌)

Taiwan·Risk Class 1·MD·VORTEX SURGICAL·Registered Apr 25, 2019 – Apr 25, 2024Expired

Registration details

Analysis ID: fdabc2ff512c3190b0202bf5eb9f1bc8
License Form: Ministry of Health Medical Device Import No. 020371
Customs Code: DHA09402037107

Company information

Manufacturer: VORTEX SURGICAL
Manufacturer Country: United States
Authorized Representative: Tiwei Wellcome Biotechnology 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 Ophthalmic devices
Product Type (Level 2): M4350 Manual Ophthalmic Surgery Instrument
Import Information: Imported from abroad

Dates and status

Registration Date: Apr 25, 2019
Expiry Date: Apr 25, 2024

About this record

Access comprehensive regulatory information for "Vortex" Manual Ophthalmic Surgical Instrument (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 fdabc2ff512c3190b0202bf5eb9f1bc8 and manufactured by VORTEX SURGICAL. The authorized representative in Taiwan is Tiwei Wellcome Biotechnology Co., Ltd.

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