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Lumipulse G CK-MB - Taiwan Registration 39eab89b1a272825645cf0867357a1ee

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.

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39eab89b1a272825645cf0867357a1ee
Registration Details
Taiwan FDA Registration: 39eab89b1a272825645cf0867357a1ee
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Device Details

Lumipulse G CK-MB
TW: ้Œ„็ง˜ๅธ•ๆ–ฏG่‚Œ้…ธๆฟ€้…ถMBๅŒๅŠŸ้…ถๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

39eab89b1a272825645cf0867357a1ee

Ministry of Health Medical Device Import No. 031970

DHA05603197007

Company Information

Product Details

This product is used only with Lumipulse G1200 to quantitatively measure the creatine kinase MB isoenzyme (CK-MB) in human serum or plasma.

A Clinical chemistry and clinical toxicology

A1215 Creatine phosphocatalyzed?/creatine excitation or isomeric test system

Imported from abroad

Dates and Status

Dec 12, 2018

Dec 12, 2023

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