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Fresenius Kabi Freka® GastroTube, ENFit - HSA Registration DE0508346

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.

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CLASS C
DE0508346
Fresenius Kabi Freka® GastroTube, ENFit
HSA Registration Number: DE0508346
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Product Description

• long-term intragastric feeding • gastric decompression For use in a healed stoma tract.

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 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