Taiwan FDA registration 7fee78f639328d74c250dd476c8ea03f
"Arkray" Lactate Pro2 Test Strip (Non-Sterile)
TW: "愛科來"乳酸檢測試紙(未滅菌)
Taiwan·Risk Class 1·MD·i-SENS Songdo Factory·Registered Jul 04, 2019 – Jul 04, 2024ExpiredRegistration details
- Analysis ID
- 7fee78f639328d74c250dd476c8ea03f
- License Form
- Ministry of Health Medical Device Import No. 020618
- Customs Code
- DHA09402061802
Company information
- Manufacturer
- i-SENS Songdo Factory
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- SYNGEN BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the lactate test system (A.1450) of the management measures for medical devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1450 Lactate Test System
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 04, 2019
- Expiry Date
- Jul 04, 2024
About this record
Access comprehensive regulatory information for "Arkray" Lactate Pro2 Test Strip (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 7fee78f639328d74c250dd476c8ea03f and manufactured by i-SENS Songdo Factory. The authorized representative in Taiwan is SYNGEN BIOTECH CO., LTD..
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