Taiwan FDA registration 369296f371cd28c5232651e79449b511
"Great Affirmation" Manual Ophthalmic Surgery Instrument (Unsterile)
TW: “大肯” 手動式眼科手術器械 (未滅菌)
Registration details
- Analysis ID
- 369296f371cd28c5232651e79449b511
- Customs Code
- DHA09401436401
Company information
- Manufacturer
- Duckworth & Kent Limited
- Manufacturer Country
- United Kingdom
- Authorized Representative
- AMO ASIA LIMITED, TAIWAN BRANCH (HONG KONG)
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
- Jul 25, 2014
- Expiry Date
- Jul 25, 2029
About this record
Access comprehensive regulatory information for "Great Affirmation" Manual Ophthalmic Surgery Instrument (Unsterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 369296f371cd28c5232651e79449b511 and manufactured by Duckworth & Kent Limited. The authorized representative in Taiwan is AMO ASIA LIMITED, TAIWAN BRANCH (HONG KONG).
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