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Caesarea Niki T34 Syringe Pump - HSA Registration DE0014261

Access comprehensive regulatory information for Caesarea Niki T34 Syringe Pump in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0014261 and owned by Caesarea Medical Electronics Ltd.. The device was registered on November 08, 2013.

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
DE0014261
Caesarea Niki T34 Syringe Pump
HSA Registration Number: DE0014261
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Product Description

The T34 Syringe Pump is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, immunoglobulins, biosimilar, chemotherapeutic agents and general fluids therapy in hospital and homecare environments.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0014261
Registration Date
November 08, 2013
Change Notification Approval Date
October 04, 2021
Retention Due Date
November 07, 2025
Product Owner
Short Name
Caesarea Medical Electronics Ltd.
Address
16 Shacham Street, Industrial Park caesarea North, PO Box 4294, ISRAEL
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315 345 JALAN BESAR, SINGAPORE 208987
Model Information
Model Name(s)
Syringe Pump T34 Syringe Pump T34-1ml
Model Identifier(s)
NIKI T34 NIKI T34-N (Green; 1ml to 50ml)