Taiwan FDA registration 14b9616f6031a2a806c49415ba150442
"Odeton" manual ophthalmic surgical instruments (sterilization)
TW: “奧德同”手動式眼科手術器械(滅菌)
Taiwan·Risk Class 1·ACCUTOME, INC.·Registered Aug 23, 2012 – Aug 23, 2022CancelledRegistration details
- Analysis ID
- 14b9616f6031a2a806c49415ba150442
- Customs Code
- DHA04401209609
Company information
- Manufacturer
- ACCUTOME, INC.
- Manufacturer Country
- United States
- Authorized Representative
- EVERLIGHT INSTRUMENT 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 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
- Aug 23, 2012
- Expiry Date
- Aug 23, 2022
- Cancellation Date
- Apr 12, 2024
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Odeton" 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 14b9616f6031a2a806c49415ba150442 and manufactured by ACCUTOME, INC.. The authorized representative in Taiwan is EVERLIGHT INSTRUMENT CO., LTD..
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