Taiwan FDA registration 0060d8063c7aeba796d25ea22a81ad64
"Ecola" lactate dehydrogenase test strip (unsterilized)
TW: "愛科來" 乳酸脫氫酶檢測試紙 (未滅菌)
Taiwan·Risk Class 1·Arkray Factory Inc., Head office factory·Registered Dec 09, 2022 – Dec 09, 2027ActiveRegistration details
- Analysis ID
- 0060d8063c7aeba796d25ea22a81ad64
- Customs Code
- DHA09402297602
Company information
- Manufacturer
- Arkray Factory Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the classification and grading management method of medical equipment "lactate dehydrogenase test system (A.1440)" level first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1440 Lactate Dehydrogenase Test System
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 09, 2022
- Expiry Date
- Dec 09, 2027
About this record
Access comprehensive regulatory information for "Ecola" lactate dehydrogenase test strip (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0060d8063c7aeba796d25ea22a81ad64 and manufactured by Arkray Factory Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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