Taiwan FDA registration 99449091b17556c3edcd25b0ae785833
"Arkola" alanine transaminase test strip (unsterilized)
TW: "愛科來" 丙胺酸轉胺酶檢測試紙(未滅菌)
Taiwan·Risk Class 1·ARKRAY Factory, Inc., Head office factory·Registered Dec 14, 2022 – Dec 14, 2027ActiveRegistration details
- Analysis ID
- 99449091b17556c3edcd25b0ae785833
- Customs Code
- DHA09402298003
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, alanine transaminase test system (A.1030) first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1030 丙胺酸轉胺酶試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Dec 14, 2022
- Expiry Date
- Dec 14, 2027
About this record
Access comprehensive regulatory information for "Arkola" alanine transaminase 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 99449091b17556c3edcd25b0ae785833 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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