Taiwan FDA registration ddeb1ca808c456ba71de9300d7ae4ff3

"Osco" Hand Ophthalmic Surgical Device (Indepleted Bacteria)

TW: "歐斯科" 手動式眼科手術器械(未滅菌)

Taiwan·Risk Class 1·Katena Products, Inc.·Registered May 16, 2024 – May 16, 2029Active

Registration details

Analysis ID: ddeb1ca808c456ba71de9300d7ae4ff3
Customs Code: DHA09402347508

Company information

Manufacturer: Katena Products, Inc.
Manufacturer Country: United States
Authorized Representative: SHIN SHENG PHARMACEUTICAL 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: Input;; QMS/QSD

Dates and status

Registration Date: May 16, 2024
Expiry Date: May 16, 2029

About this record

Access comprehensive regulatory information for "Osco" Hand Ophthalmic Surgical Device (Indepleted Bacteria) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number ddeb1ca808c456ba71de9300d7ae4ff3 and manufactured by Katena Products, Inc.. The authorized representative in Taiwan is SHIN SHENG PHARMACEUTICAL CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.