Singapore HSA registration DE0510047
HYPHEN BIOPHEN DiXal
Singapore·CLASS C IVD·HYPHEN BioMed·Registered November 15, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510047
- Registration Date
- November 15, 2024
- Retention Due Date
- November 14, 2025
Product description
Anti-Xa chromogenic method for the in vitro quantitative determination of direct Factor Xa inhibitors (DiXaIs), in human citrated plasma, using an automated method. This method is for aid to diagnosis to detect anticoagulant status (Apixaban, Rivaroxaban and Edoxaban) in patients on oral anticoagulants therapy. This device of in vitro diagnostic use is intended for professional use in the laboratory.
Product Owner
- Name
- HYPHEN BioMed
- Short Name
- HYPHEN BioMed
- Address
- 155 rue d'Eragny, 95000 Neuville-sur-Oise, FRANCE
Registrant
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
- Address
- 9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model information
- Model Name(s)
- PNEUMATIC UNIT PU-17 Automated Blood Coagulation Analyzer CS-2000i Automated Blood Coagulation Analyzer CS-2100i SB Cuvette CUVETTE, SUC-400A BIOPHEN DiXal BIOPHEN Rivaroxaban Plasma Calibrator BIOPHEN Rivaroxaban Control Plasma BIOPHEN Rivaroxaban Control Low BIOPHEN Apixaban Control Low BIOPHEN Apixaban Control BIOPHEN Edoxaban Control Low BIOPHEN Edoxaban Control BIOPHEN Rivaroxaban Calibrator Low BIOPHEN Apixaban Calibrator Low BIOPHEN Apixaban Calibrator BIOPHEN Edoxaban Calibrator Low BIOPHEN Edoxaban Calibrator CN Series Protocol Disc REACTION TUBE, SU-40 CA CLEAN II CA CLEAN I CA CLEAN II TU-40 Transportation Unit Automated Blood Coagulation Analyzer CS-2400 Automated Blood Coagulation Analyzer CN-3500 CN-COAGWASHER Automated Blood Coagulation Analyzer CN-6500 Automated Blood Coagulation Analyzer CS-1600 CA CLEAN II BT-40 Transportation Unit Automated Blood Coagulation Analyzer CS-2500 Option Sampler SA-90 Automated Blood Coagulation Analyzer CS-5100 CV-70 Transportation Unit CS-1600 Protocol Disc CS- Series Protocol Disc CV-60 Transportation Unit ST-40 Transportation Unit Automated Blood Coagulation Analyzer CN-3000 SB Cuvette II Automated Blood Coagulation Analyzer CN-6000 ST-42 Transportation Unit
- Model Identifier(s)
- 1330061 6317410 6372511 064-1041-9 064-1481-0 221030 222701 224501 225101 225201 225301 225401 225501 226001 226101 226201 226401 226501 3CNSX 904-0721-9 964-0611-9 964-0631-3 974-0581-0 AN617358 AR780981 AX818921 AZ700649 BH584790 BQ203979 BT-565-104 BT080317 BV981798 BX718746 BY990757 CC652805 CDR2C16X CDR4CS2X CE944580 CJ256159 CL971029 CM-500-820 CV339763 CV979713
About this record
Access comprehensive regulatory information for HYPHEN BIOPHEN DiXal 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 DE0510047 and owned by HYPHEN BioMed. The device was registered on November 15, 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