Lumipulse G CK-MB
Taiwan·Risk Class 2·MD·FUJIREBIO INC. SAGAMIHARA FACILITY.·Registered Dec 12, 2018 – Dec 12, 2023Expired- Analysis ID
- 39eab89b1a272825645cf0867357a1ee
- License Form
- Ministry of Health Medical Device Import No. 031970
- Customs Code
- DHA05603197007
- Manufacturer
- FUJIREBIO INC. SAGAMIHARA FACILITY.
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
- Intended Use
- This product is used only with Lumipulse G1200 to quantitatively measure the creatine kinase MB isoenzyme (CK-MB) in human serum or plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1215 Creatine phosphocatalyzed?/creatine excitation or isomeric test system
- Import Information
- Imported from abroad
- Registration Date
- Dec 12, 2018
- Expiry Date
- Dec 12, 2023
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Access comprehensive regulatory information for Lumipulse G CK-MB in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 39eab89b1a272825645cf0867357a1ee and manufactured by FUJIREBIO INC. SAGAMIHARA FACILITY.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including FUJIREBIO, Inc., Hachioji Facility, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.