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Singapore HSA registration DE0507305

Fresenius Kabi Freka® PEG Gastric Tubes

Singapore flagSingapore·CLASS D·Fresenius Kabi AG·Registered September 26, 2022
Device classification
Device Class
CLASS D
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0507305
Registration Date
September 26, 2022
Change Notification Approval Date
October 25, 2024
Retention Due Date
September 25, 2026
Product description
Indicated for long-term intragastric feeding in patients with inadequate oral nutritional intake (< 60% of the calculated energy supply) and the need for nutritional feeding for a period exceeding 2-3 weeks and palliative gastric decompression/drainage by gravity in the presence of a chronic gastrointestinal stenosis or ileus.
Product Owner
Name
Fresenius Kabi AG
Short Name
Fresenius Kabi
Address
61346 Bad Homburg, GERMANY
Registrant
Name
FRESENIUS KABI (SINGAPORE) PTE LTD
Address
238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Importer
Name
FRESENIUS KABI (SINGAPORE) PTE LTD
Address
238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Model information
Model Name(s)
Freka® PEG FR9, ENFit Freka® PEG FR15, ENFit Freka® PEG FR20, ENFit Freka® Intestinal Tube FR9 for PEG FR15, ENFit Freka® Intestinal Tube FR12 for Freka® PEG FR20, ENFit Freka® Repair set for Freka® PEG FR9, ENFit Freka® Repair set for Freka PEG FR15, ENFit Freka® Repair set for Freka® PEG FR20, ENFit
Model Identifier(s)
7755642 7755643 7755644 7755646 7755647 7981382 7981383 7981384
About this record

Access comprehensive regulatory information for Fresenius Kabi Freka® PEG Gastric Tubes in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507305 and owned by Fresenius Kabi AG. The device was registered on September 26, 2022.

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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