Taiwan FDA registration 3c4cddc8f139dc1be7707524008b2b3c
"Badietek" immunofluorescence analyzer (unsterilized)
TW: “巴迪鐵克”免疫螢光分析儀(未滅菌)
Taiwan·Risk Class 1·Boditech Med Inc.·Registered Oct 04, 2021 – Oct 31, 2023CancelledRegistration details
- Analysis ID
- 3c4cddc8f139dc1be7707524008b2b3c
- Customs Code
- DHA084a0001000
Company information
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management measures of medical equipment "fluorescence instrument for clinical use (A.2560)" the first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2560 Fluorometer for clinical use
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 04, 2021
- Expiry Date
- Oct 31, 2023
- Cancellation Date
- Nov 02, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Badietek" immunofluorescence analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3c4cddc8f139dc1be7707524008b2b3c and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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