Singapore HSA registration DE0503143
Nipro Surdial X Single Patient Dialysis Machine
Singapore·CLASS C·NIPRO CORPORATION·Registered May 24, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0503143
- Registration Date
- May 24, 2019
- Change Notification Approval Date
- November 22, 2019
- Retention Due Date
- May 23, 2025
Product description
The Surdial-X can be used for patients with acute or chronic renal failure and when hemodialysis is prescribed by a physician. The Surdial-X is intended to be used by trained operators for hospital, health center or limited care. The system is a single patient hemodialysis system, which provides dialysis fluid with a prescribed concentration and temperature to be used for hemodialysis treatment. The system is intended to be used with high and low permeability dialyzers. The Surdial-X monitors during the dialysis treatment dialysate, blood circuit and machine functions. The system tolerances (e.g. Fluid balance, air infusion) are designed to treat patients with their body weight of 30kg or more.
Product Owner
- Short Name
- NIPRO CORPORATION
- Address
- 3-9-3, Honjo-Nishi, Kita-ku,, 531-8510, JAPAN
Registrant
- Address
- 6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
- Address
- 6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Model information
- Model Name(s)
- Surdial X Single Patient Dialysis Machine
- Model Identifier(s)
- Surdial X
About this record
Access comprehensive regulatory information for Nipro Surdial X Single Patient Dialysis Machine in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503143 and owned by NIPRO CORPORATION. The device was registered on May 24, 2019.
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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