Singapore HSA registration DE0510710
Neoventa AB Goldtrace Fetal Spiral Electrode (FSE)
Singapore·CLASS B·Neoventa Medical AB·Registered May 09, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Obstetrics & Gynaecology
Registration information
- Registration Number
- DE0510710
- Registration Date
- May 09, 2025
- Retention Due Date
- May 08, 2026
Product description
Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.
Product Owner
- Short Name
- Neoventa Medical AB
- Address
- Norra Ågatan 32, SE-431 35 Mölndal, SWEDEN
Registrant
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Importer
- Name
- ALCOTECH PTE LTD
- Address
- 25 BUKIT BATOK CRESCENT, THE ELITIST, #09-13, SINGAPORE 658066
Model information
- Model Name(s)
- Goldtrace Fetal Spiral Electrode (FSE)
- Model Identifier(s)
- CNS000004
About this record
Access comprehensive regulatory information for Neoventa AB Goldtrace Fetal Spiral Electrode (FSE) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510710 and owned by Neoventa Medical AB. The device was registered on May 09, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B