Taiwan FDA registration ad95dc108181ff023e299751a060550f
“Diasys”α-Amylase CC FS
TW: “德信”澱粉酶檢驗試劑
Taiwan·Risk Class 2·MD·DIASYS DIAGNOSTIC SYSTEMS GMBH·Registered Jul 25, 2018 – Jul 25, 2028ActiveRegistration details
- Analysis ID
- ad95dc108181ff023e299751a060550f
- License Form
- Ministry of Health Medical Device Import No. 031329
- Customs Code
- DHA05603132902
Company information
- Manufacturer
- DIASYS DIAGNOSTIC SYSTEMS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- This product is a diagnostic agent used in optical colorimetric analysis instruments to quantify amylase concentrations in serum, plasma, or urine.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1070 Amylase Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 25, 2018
- Expiry Date
- Jul 25, 2028
About this record
Access comprehensive regulatory information for “Diasys”α-Amylase CC FS in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ad95dc108181ff023e299751a060550f and manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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