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Singapore HSA registration DE0504396

Technoclone TECHNOZYM® ADAMTS-13 INH

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
DE0504396
Registration Date
April 27, 2020
Retention Due Date
April 26, 2026
Product description
The TECHNOZYM® ADAMTS-13 INH ELISA is a test for detection of human autoantibodies (IgG) in serum or plasma against ADAMTS-13, the protease which is responsible for cleaving unusually large vWF (ULvWF). Most of these autoantibodies inhibit ADAMTS-13 activity and thus non-cleaved ULvWF accumulates in plasma. This is believed to be the major cause for thrombotic thrombocytopenic purpura (TTP). TECHNOZYM® ADAMTS-13 INH test makes it possible to differentiate between congenital (gene polymorphisms) and acquired (autoantibodies) TTP when coupled to an activity assay and to control efficacy of plasma exchange therapy.
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 INH TECHNOZYM® ADAMTS-13 INH TECHNOZYM® ADAMTS-13 INH Calibrator Set TECHNOZYM® ADAMTS-13 INH Control Set
Model Identifier(s)
5450401 (96 T) 5450451 (48 T) 5450461 5450463
About this record

Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 INH 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 DE0504396 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