Taiwan FDA registration 7d32ecd462ad02fe1d70924d9185a9c8

Emanutec bone-specific alkaline phosphatase reagent

TW: 伊曼紐特克骨質特異性鹼性磷酸酶試劑

Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered May 03, 2023 – May 03, 2028Active

Registration details

Analysis ID: 7d32ecd462ad02fe1d70924d9185a9c8
Customs Code: DHAS5603616808

Company information

Manufacturer: IMMUNOTECH S.R.O.
Manufacturer Country: Czechia
Authorized Representative: MEGA BONA INTERNATIONAL CO., LTD.

Product details

Intended Use: This product uses external radioimmunoassay to determine bone-specific alkaline phosphatase in human serum.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1050 Alkaline phosphatase or isoenzyme testing system
Import Information: Consent must be attached to the import (with the consent of the Atomic Energy Commission must be obtained for each import); QMS/QSD;; input

Dates and status

Registration Date: May 03, 2023
Expiry Date: May 03, 2028

About this record

Access comprehensive regulatory information for Emanutec bone-specific alkaline phosphatase reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7d32ecd462ad02fe1d70924d9185a9c8 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is MEGA BONA INTERNATIONAL CO., LTD..

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