Taiwan FDA registration 5ed43604352d8bea5dfb3e49427b1ce6
“SEIKEN” Multi Calibrator NX
TW: “生研” 免疫試劑多項校正液
Taiwan·Risk Class 2·MD·DENKA CO., LTD·Registered Oct 07, 2015 – Oct 07, 2025ExpiredRegistration details
- Analysis ID
- 5ed43604352d8bea5dfb3e49427b1ce6
- License Form
- Ministry of Health Medical Device Import No. 027711
- Customs Code
- DHA05602771107
Company information
- Manufacturer
- DENKA CO., LTD
- Manufacturer Country
- Japan
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- This product provides DENKA SEIKEN reagents to generate calibration curves to quantify proteins such as IgG, IgA, IgM, C3 and C4 in plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 07, 2015
- Expiry Date
- Oct 07, 2025
About this record
Access comprehensive regulatory information for “SEIKEN” Multi Calibrator NX in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5ed43604352d8bea5dfb3e49427b1ce6 and manufactured by DENKA CO., LTD. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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