Taiwan FDA registration 97fd510e502cfcdb3320f12dfee472a6

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

TW: "泰可芬" 手動式眼科手術器械 (未滅菌)

Taiwan·Risk Class 1·MD·TECFEN MEDICAL·Registered Nov 16, 2018 – Nov 16, 2023Expired

Registration details

Analysis ID: 97fd510e502cfcdb3320f12dfee472a6
License Form: Ministry of Health Medical Device Import No. 019825
Customs Code: DHA09401982507

Company information

Manufacturer: TECFEN MEDICAL
Manufacturer Country: United States
Authorized Representative: BOULDER ENTERPRISE 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: Nov 16, 2018
Expiry Date: Nov 16, 2023

About this record

Access comprehensive regulatory information for "Tecfen" 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 97fd510e502cfcdb3320f12dfee472a6 and manufactured by TECFEN MEDICAL. The authorized representative in Taiwan is BOULDER ENTERPRISE CO., LTD..

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