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ICU IV Administration/Transfer Set with EasyDrop Flow Regulator - HSA Registration DE0017903

Access comprehensive regulatory information for ICU IV Administration/Transfer Set with EasyDrop Flow Regulator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017903 and owned by ICU Medical Inc.. The device was registered on February 26, 2016.

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 B
DE0017903
ICU IV Administration/Transfer Set with EasyDrop Flow Regulator
HSA Registration Number: DE0017903
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Product Description

The intended use is to provide access for the administration of fluids from a container to a patientโ€™s vascular system through the administration setโ€™s needle or catheter (which is inserted into a vein).

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00110
HS Code
90183990
Registration Information
Registration Number
DE0017903
Registration Date
February 26, 2016
Change Notification Approval Date
January 13, 2022
Retention Due Date
February 25, 2026
Product Owner
Short Name
ICU Medical Inc.
Address
951 Calle Amanecer San Clemente, CA 92673, UNITED STATES
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #04-30, SINGAPORE 408729
Model Information
Model Name(s)
75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/Easydrop Flow Controller, Rotating Luer
Model Identifier(s)
011-C9823