Taiwan FDA registration 46afc61fdb150a9782de61060453cb59

Manual Ophthalmic Surgical Instruments (Sterilization)

TW: "醫勾雷柏" 手動式眼科手術器械 (滅菌)
Taiwan flagTaiwan·Risk Class 1·EAGLE LABS, LLC·Registered Nov 09, 2021 – Nov 09, 2026Active
Registration details
Analysis ID
46afc61fdb150a9782de61060453cb59
Customs Code
DHA09402269402
Company information
Manufacturer
EAGLE LABS, LLC
Manufacturer Country
United States
Authorized Representative
BIOMEGA INSTRUMENT CO., LTD.
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
Dates and status
Registration Date
Nov 09, 2021
Expiry Date
Nov 09, 2026
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About this record

Access comprehensive regulatory information for Manual Ophthalmic Surgical Instruments (Sterilization) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 46afc61fdb150a9782de61060453cb59 and manufactured by EAGLE LABS, LLC. The authorized representative in Taiwan is BIOMEGA INSTRUMENT CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including OASIS MEDICAL INC., D.O.R.C. Dutch Ophthalmic Research Center (INTERNATIONAL) B.V., and 5 recent registrations in the same category. 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.

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