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Diagnostica Stago STA® ImmunoDef IX - HSA Registration DE0506532

Access comprehensive regulatory information for Diagnostica Stago STA® ImmunoDef IX 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 DE0506532 and owned by Diagnostica Stago S.A.S. The device was registered on December 29, 2021.

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.

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CLASS B IVD
DE0506532
Diagnostica Stago STA® ImmunoDef IX
HSA Registration Number: DE0506532
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Product Description

STA® - ImmunoDef IX is an immuno-depleted human plasma intended for use in tests for the determination of factor IX (antihemophilic B factor) activity in plasma on STA-R® and STA Compact®. These tests require the inclusion of factor IX deficient plasma.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0506532
Registration Date
December 29, 2021
Change Notification Approval Date
March 18, 2025
Retention Due Date
December 28, 2025
Product Owner
Short Name
Diagnostica Stago S.A.S
Address
3 allée Thérésa, 92600 Asnières sur Seine, FRANCE
Registrant
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
Address
6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model Information
Model Name(s)
STA® - Owren-Koller STA® - CaCl2 0.025 M STA® - C.K. Prest® STA® - Unicalibrator STA® - System Control N+P STA - ImmunoDef IX STA-R Evolution® STA-R Evolution® STA R Max® STA R Max® STA R Max® STA R Max® STA Compact® STA Compact® STA Compact® STA Compact® STA Compact® CT STA Compact® CT STA Compact Max® STA Compact Max® STA Compact Max® STA Compact Max®
Model Identifier(s)
360 367 597 675 678 734 58151 58154 58404 58405 58406 58407 58606 58616 58624 58639 58640 58672 58712 58713 58732 58733