Singapore HSA registration DE0000548
Gambro Prismaflex™ HF Disposable Set
Singapore·CLASS C·Gambro Industries·Registered May 03, 2005Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0000548
- Registration Date
- May 03, 2005
- Change Notification Approval Date
- October 03, 2024
- Retention Due Date
- August 09, 2025
Product description
The Prismaflex set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered)in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. This set is intended for use in the following veno-venous therapies: SCUF; CVVH;CVVHD; CVVHDF.
Product Owner
- Short Name
- Gambro Industries
- Address
- 7, Avenue Lionel Terray, BP 126, 69883 Meyzieu Cedex, FRANCE
Registrant
- Address
- 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
- Address
- 150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model information
- Model Name(s)
- Prismaflex HF 20 Set
- Model Identifier(s)
- 109841
About this record
Access comprehensive regulatory information for Gambro Prismaflex™ HF Disposable Set in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0000548 and owned by Gambro Industries. The device was registered on May 03, 2005.
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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