HSA · registration DE0510058Diagnostica Stago STA® - NeoPTimal
- Registration number
- DE0510058
- Model name
- 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
- 00360; 00496; 00554; 00617; 00621; 00625; 00678; 00679; 01163; 01164; 01165; 58030; 58404; 58405; 58406; 58407; 58712; 58713; 58732; 58733; 59017
- Registration date
- November 20, 2024
- Source update date
- August 19, 2025
- Risk class
- Class C
- Product owner
- Diagnostica Stago S.A.S
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
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 address
- 3 allée Thérésa - CS 10009, 92665 Asnières sur Seine Cedex, France
- Registrant address
- 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.