Taiwan FDA registration 96f9b58b861b4e15b0d5da3009ef4979
"Romandy" endoscope attachment (unsterilized)
TW: "羅曼迪" 內視鏡附件 (未滅菌)
Taiwan·Risk Class 1·LUMENDI, LLC·Registered Sep 04, 2020 – Sep 04, 2025ExpiredRegistration details
- Analysis ID
- 96f9b58b861b4e15b0d5da3009ef4979
- Customs Code
- DHA09402193101
Company information
- Manufacturer
- LUMENDI, LLC
- Manufacturer Country
- United States
- Authorized Representative
- DOUBLE-SUCCESS CO., LTD.
Product details
- Intended Use
- Limited to the first level recognition range of the "endoscope and its accessories (H.1500)" of the Measures for the Classification and Grading Management of Medical Equipment.
- Product Type (Level 1)
- H Gastroenterology and urology
- Product Type (Level 2)
- H.1500 Internal Scope and its accessories
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Sep 04, 2020
- Expiry Date
- Sep 04, 2025
About this record
Access comprehensive regulatory information for "Romandy" endoscope attachment (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 96f9b58b861b4e15b0d5da3009ef4979 and manufactured by LUMENDI, LLC. The authorized representative in Taiwan is DOUBLE-SUCCESS 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.
Free DatabasePowered by Pure Global AI89,000+ Devices