Singapore HSA registration DE0510315
Finapres NOVA
Singapore·CLASS B·Finapres Medical Systems B.V.·Registered February 07, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510315
- Registration Date
- February 07, 2025
- Retention Due Date
- February 06, 2026
Product description
The Finapres® NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres® NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermodilution.
Product Owner
- Short Name
- Finapres Medical Systems B.V.
- Address
- Institutenweg 25 7521, PH ENSCHEDE, NETHERLANDS
Registrant
- Address
- 8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
- Address
- 8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model information
- Model Name(s)
- Valsalva assembly Finapres® Nova NC Basic Finapres® Nova NC ECG + RESP Finapres® Nova NC SpO₂ Finapres® Nova NC Full Options Autonomic Testing application Hemodynamics Modelflow application HL7 Connect Finapres Nova Remote Control application Finapres Nova Scope application (5 Licenses) Guided Autonomic Testing application GAT Valsalva accessories Finger cuff (size S) Finger cuff (size M) Finger cuff (size L) Height Correction Unit Adult SpO2 Sensor
- Model Identifier(s)
- D222351 FP_N03.280 FP_N03.283 FP_N03.284 FP_N03.287 FP_N98.002 FP_N98.004 FP_N98.007 FP_N98.008 FP_N98.016 FP_N98.G01 FP_N98.G02 FP_N99.C06 FP_N99.C07 FP_N99.C08 FP_N99.H03 FP_N99.S02 (DS100A)
About this record
Access comprehensive regulatory information for Finapres NOVA in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510315 and owned by Finapres Medical Systems B.V.. The device was registered on February 07, 2025.
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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