Taiwan FDA registration 8be29ed560c45f9294291f17320ec1f1
"NanoEnTek" ADAM-rWBC
TW: "奈科" 白血球計數器
Taiwan·Risk Class 2·MD·NANOENTEK INC.·Registered Sep 15, 2017 – Sep 15, 2027ActiveRegistration details
- Analysis ID
- 8be29ed560c45f9294291f17320ec1f1
- License Form
- Ministry of Health Medical Device Import No. 029853
- Customs Code
- DHA05602985301
Company information
- Manufacturer
- NANOENTEK INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Y.H. BIOTEK CO., LTD.
Product details
- Intended Use
- This product is used to count the remaining white blood cells in blood components after subtracting white blood cells during blood transfusion.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B5220 automatically differentiates cell counters
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 15, 2017
- Expiry Date
- Sep 15, 2027
About this record
Access comprehensive regulatory information for "NanoEnTek" ADAM-rWBC in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8be29ed560c45f9294291f17320ec1f1 and manufactured by NANOENTEK INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..
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