Taiwan FDA registration 247cefba9d8070bf764eaf9403142a22
“NanoEnTek” ADAM-rWBC Kit
TW: “奈科” 白血球計數套組
Taiwan·Risk Class 2·MD·NANOENTEK INC.·Registered Dec 01, 2016 – Dec 01, 2026ActiveRegistration details
- Analysis ID
- 247cefba9d8070bf764eaf9403142a22
- License Form
- Ministry of Health Medical Device Import No. 029153
- Customs Code
- DHA05602915309
Company information
- Manufacturer
- NANOENTEK INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Y.H. BIOTEK CO., LTD.
Product details
- Intended Use
- This product is designed to count remaining white blood cells (rWBCs) in leukocytes-depleted blood products.
- 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
- Dec 01, 2016
- Expiry Date
- Dec 01, 2026
About this record
Access comprehensive regulatory information for “NanoEnTek” ADAM-rWBC Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 247cefba9d8070bf764eaf9403142a22 and manufactured by NANOENTEK INC.. The authorized representative in Taiwan is Y.H. BIOTEK CO., LTD..
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