Taiwan FDA registration 3cf7c00c6fa4d6f2d759e3d2a3b81d23

Siemens Inofansparin Reagent Group

TW: 西門子伊諾凡司肝素試劑組

Taiwan·Risk Class 2·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Registered Apr 30, 2019 – Apr 30, 2029Active

Registration details

Analysis ID: 3cf7c00c6fa4d6f2d759e3d2a3b81d23
Customs Code: DHA05603241701

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer Country: Germany
Authorized Representative: SYSMEX TAIWAN CO., LTD.

Product details

Intended Use: This product uses in vitro diagnostic automatic color detection method to quantitatively detect the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in human plasma.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 calibration;; B.7525 Heparin analysis;; B.5425 Versatile system for in vitro agglutination studies
Import Information: import

Dates and status

Registration Date: Apr 30, 2019
Expiry Date: Apr 30, 2029

About this record

Access comprehensive regulatory information for Siemens Inofansparin Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3cf7c00c6fa4d6f2d759e3d2a3b81d23 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH. The authorized representative in Taiwan is SYSMEX TAIWAN CO., LTD..

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