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Singapore HSA registration DE0510058

Diagnostica Stago STA® - NeoPTimal

Singapore flagSingapore·CLASS C IVD·Diagnostica Stago S.A.S·Registered November 20, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0510058
Registration Date
November 20, 2024
Retention Due Date
November 19, 2025
Product description
The STA® - NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma, of prothrombin time (PT) on the analyzers of the STA-R®, STA Compact® and STA Satellite® families. STA® - NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).
Product Owner
Name
Diagnostica Stago S.A.S
Short Name
Diagnostica Stago S.A.S
Address
3 allée Thérésa - CS 10009, 92665 Asnières sur Seine Cedex, FRANCE
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)
STA® - Owren-Koller Etaloquick® STA® - Routine QC 2 ml System Control N + P Coag Control N + P Unicalibrator STA® - System Control N+P STA® - Coag Control N + P STA® - NeoPTimal ⑤ STA® - NeoPTimal ⑩ STA® - NeoPTimal ⑳ STA Satellite® Max STA R Max® STA R Max® STA R Max® STA R Max® STA Compact Max® STA Compact Max® STA Compact Max® STA Compact Max® Start Max®
Model Identifier(s)
360 496 554 617 621 625 678 679 1163 1164 1165 58030 58404 58405 58406 58407 58712 58713 58732 58733 59017
About this record

Access comprehensive regulatory information for Diagnostica Stago STA® - NeoPTimal in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510058 and owned by Diagnostica Stago S.A.S. The device was registered on November 20, 2024.

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 C IVD