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Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set - Taiwan Registration 8ac47fdd4b77ee7ff333d4f85c3c329e

Access comprehensive regulatory information for Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8ac47fdd4b77ee7ff333d4f85c3c329e and manufactured by LIN-ZHI INTERNATIONAL, INC. The authorized representative in Taiwan is BECKMAN COULTER TAIWAN INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details. 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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8ac47fdd4b77ee7ff333d4f85c3c329e
Registration Details
Taiwan FDA Registration: 8ac47fdd4b77ee7ff333d4f85c3c329e
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Device Details

Beckman Coulter Gnosis Ekantamine Enzyme Immunoassay Set
TW: ่ฒๅ…‹ๆ›ผๅบซ็ˆพ็‰น้ˆ็Ÿฅๆ˜“ๆ„ทไป–ๅ‘ฝ้…ต็ด ๅ…็–ซๅˆ†ๆž่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

8ac47fdd4b77ee7ff333d4f85c3c329e

DHA05603569403

Company Information

Product Details

This product is used for qualitative and semi-quantitative determination of norketamine in human urine with a critical value of 50 ng/mL (when corrected for norketamine).

A Clinical chemistry and clinical toxicology

A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.0001 ่‹ฏ็’ฐๅˆฉๅฎš่ฉฆ้ฉ—็ณป็ตฑ

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Aug 19, 2022

Aug 19, 2027