Taiwan FDA registration 28e86da9e3451ab44e815c3a3c02bfa8
Apco second generation blood analysis test cassette
TW: 艾波可第二代血液分析檢測卡匣
Taiwan·Risk Class 2·Siemens Healthcare Diagnostics Inc.;; EPOCAL INC.·Registered Oct 13, 2017 – Oct 13, 2027ActiveRegistration details
- Analysis ID
- 28e86da9e3451ab44e815c3a3c02bfa8
- Customs Code
- DHA05603006703
Company information
- Manufacturer Country
- Canada;;United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is used with epoc Reader and epoc Host to quantitatively detect the concentration of Na+, K+, Ca2+, Cl-, pH, pCO2, Hct, Lactate, Creatinine, and Glucose in arterial, venous or microvascular whole blood samples.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1120 血內氣體(PCO2,PO2)及血液pH值試驗系統;; A.1665 鈉試驗系統;; A.1345 葡萄糖試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Oct 13, 2017
- Expiry Date
- Oct 13, 2027
About this record
Access comprehensive regulatory information for Apco second generation blood analysis test cassette in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 28e86da9e3451ab44e815c3a3c02bfa8 and manufactured by Siemens Healthcare Diagnostics Inc.;; EPOCAL INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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