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Singapore HSA registration DE0016368

NIPRO ELISIO Synthetic HEMODIALYZER

Singapore flagSingapore·CLASS C·NIPRO CORPORATION·Registered September 30, 2014
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0016368
Registration Date
September 30, 2014
Change Notification Approval Date
July 29, 2024
Retention Due Date
September 29, 2025
Product description
Hemodialysis or Hemodiafiltration with ELISIO-H is indicated for patients having acute or chronic renal failure when dialysis is prescribed by the physician. Hemodialysis with ELISIO-M and -L is indicated for patients having acute or chronic renal failure when dialysis is prescribed by the physician.
Product Owner
Name
NIPRO CORPORATION
Short Name
NIPRO CORPORATION
Address
3-26 Senriokashinmachi, Settsu, Osaka, 566-8510, JAPAN
Registrant
Name
NIPRO ASIA PTE LTD
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986
Importer
Name
NIPRO ASIA PTE LTD Omni-Med Marketing Pte Ltd
Address
6 TEMASEK BOULEVARD, SUNTEC TOWER FOUR, #31-01/02, SINGAPORE 038986 10 JOO KOON CRESCENT, SINGAPORE 629012
Model information
Model Name(s)
Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron Synthetic Hollow Fiber Polynephron
Model Identifier(s)
ELISIO-13H ELISIO-13M ELISIO-15H ELISIO-15L ELISIO-15M ELISIO-17H ELISIO-17L ELISIO-17M ELISIO-19H ELISIO-19L ELISIO-19M ELISIO-21H ELISIO-21L ELISIO-21M ELISO-13L
About this record

Access comprehensive regulatory information for NIPRO ELISIO Synthetic HEMODIALYZER in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016368 and owned by NIPRO CORPORATION. The device was registered on September 30, 2014.

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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