Singapore HSA registration DE0508346
Fresenius Kabi Freka® GastroTube, ENFit
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0508346
- Registration Date
- July 31, 2023
- Change Notification Approval Date
- January 24, 2024
- Retention Due Date
- July 30, 2025
Product description
• long-term intragastric feeding • gastric decompression For use in a healed stoma tract.
Product Owner
- Short Name
- Fresenius Kabi AG
- Address
- Else-Kröner-Str.1,, 61352 Bad Homburg, GERMANY
Registrant
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Importer
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Model information
- Model Name(s)
- Freka® Gastrotube FR15, ENFit
- Model Identifier(s)
- 7755648
About this record
Access comprehensive regulatory information for Fresenius Kabi Freka® GastroTube, ENFit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508346 and owned by Fresenius Kabi AG. The device was registered on July 31, 2023.
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