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Singapore HSA registration DE0504395

Technoclone TECHNOZYM® ADAMTS-13 Antigen

Singapore flagSingapore·CLASS B IVD·Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH·Registered April 27, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0504395
Registration Date
April 27, 2020
Retention Due Date
April 26, 2026
Product description
The TECHNOZYM® ADAMTS-13 Antigen ELISA is a chromogenic test for the determination of ADAMTS-13 antigen concentration in human plasma. ADAMTS-13 is the enzyme that cleaves vWF under laminar flow conditions. A functional defect of this enzyme leads to the presence of higher molecular weight forms of vWF and thus to increased platelet aggregation, mainly in the microvasculature. This is believed to be the major cause for thrombotic thrombocytopenic Purpura (TTP).
Product Owner
Name
Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Short Name
Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Address
Brunner Str. 67, 1230 Vienna, AUSTRIA
Registrant
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Name
ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
Model Name(s)
TECHNOZYM® ADAMTS-13 Antigen TECHNOZYM� ADAMTS-13 Antigen Calibrator Set TECHNOZYM� ADAMTS-13 Antigen Control Set
Model Identifier(s)
5450601 5450661 5450663
About this record

Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 Antigen in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0504395 and owned by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. The device was registered on April 27, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD