Taiwan FDA registration c63b09634edbb9f5389135fcbcca12a8
"Radiometer" blood gas analyzer system
TW: “雷度”血液氣體分析儀系統
Taiwan·Risk Class 2·Radiometer Medical ApS;; SenDx Medical, Inc.·Registered May 08, 2019 – May 08, 2029ActiveRegistration details
- Analysis ID
- c63b09634edbb9f5389135fcbcca12a8
- Customs Code
- DHA05603242704
Company information
- Manufacturer
- Radiometer Medical ApS;; SenDx Medical, Inc.
- Manufacturer Country
- United States;;Denmark
- Authorized Representative
- MEDTRUST INTERNATIONAL CO., LTD.
Product details
- Intended Use
- This product is a mobile automated analyzer that can be used to measure pH, blood gas, electrolytes, lactate, and hematocrit in whole blood.
- 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
- Import Information
- import
Dates and status
- Registration Date
- May 08, 2019
- Expiry Date
- May 08, 2029
About this record
Access comprehensive regulatory information for "Radiometer" blood gas analyzer system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c63b09634edbb9f5389135fcbcca12a8 and manufactured by Radiometer Medical ApS;; SenDx Medical, Inc.. The authorized representative in Taiwan is MEDTRUST INTERNATIONAL CO., LTD..
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