Taiwan FDA registration 412db1022bf0aef2e31d30ae16137030
"Arkulai" R-glutamyltransferase test strip (unsterilized)
TW: "愛科來" r-麩胺醯轉移酶檢測試紙(未滅菌)
Taiwan·Risk Class 1·ARKRAY Factory, Inc., Head office factory·Registered Dec 30, 2022 – Dec 30, 2027ActiveRegistration details
- Analysis ID
- 412db1022bf0aef2e31d30ae16137030
- Customs Code
- DHA09402299401
Company information
- Manufacturer
- ARKRAY Factory, Inc., Head office factory
- Manufacturer Country
- Japan
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Classification and grading management measures for medical devices "r-glutaminyl transferase (GGT) and isoenzyme test system (A.1360) first grade identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1360 r-麩胺醯轉移酶(GGT)和同功酶試驗系統
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 30, 2022
- Expiry Date
- Dec 30, 2027
About this record
Access comprehensive regulatory information for "Arkulai" R-glutamyltransferase 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 412db1022bf0aef2e31d30ae16137030 and manufactured by ARKRAY Factory, Inc., Head office factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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