Taiwan FDA registration 5038a49d926455481ed1fe2bed5979aa
Ambimetric lipid test specimens (unsterilized)
TW: 安必測 脂質檢驗試片 (未滅菌)
Taiwan·Risk Class 1·SD BIOSENSOR, INC.·Registered Apr 14, 2017 – Apr 14, 2022CancelledRegistration details
- Analysis ID
- 5038a49d926455481ed1fe2bed5979aa
- Customs Code
- DHA09401771006
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- IXENSOR CO., LTD.
Product details
- Intended Use
- It is limited to the first level identification range of "cholesterol (total) test system (A.1175)", "lipoprotein test system (A.1475)" and "triglyceride test system (A.1705)" of the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1475 Lipoprotein Testing System;; A.1705 Triglyceride test system;; A.1175 Cholesterol (Total) Testing System
- Import Information
- import
Dates and status
- Registration Date
- Apr 14, 2017
- Expiry Date
- Apr 14, 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 Ambimetric lipid test specimens (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5038a49d926455481ed1fe2bed5979aa and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is IXENSOR CO., LTD..
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