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ICU Microclave - HSA Registration DE0507015

Access comprehensive regulatory information for ICU Microclave in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507015 and owned by ICU Medical, Inc.. The device was registered on June 27, 2022.

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
DE0507015
ICU Microclave
HSA Registration Number: DE0507015
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Product Description

Administration Sets are intended for administration of fluids, medications or blood from a container to a patient’s vascular system.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507015
Registration Date
June 27, 2022
Change Notification Approval Date
November 24, 2022
Retention Due Date
June 26, 2025
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)
MicroClave™ Clear Connector MicroClave™ Clear Connector w/Green Ring MicroClave™ Clear Connector w/Red Ring MicroClave™ Clear Connector w/Yellow Ring Ext Set, Smallbore w/Clave™ Clear MicroClave Clear w/ Check Valve 11 cm (4.5") Smallbore Quadfuse Ext Set w/4 MicroClave Clear, 4 Clamps, Rotating Luer 4-Way Stopcock w/ 2 MicroClave Clear
Model Identifier(s)
011-MC100 011-MC100GR 011-MC100RR 011-MC100YR 011-MC330149 011-MC33036 011-MC330567 011-MC33108