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ICU Medical Chemoclave Transfer system - HSA Registration DE0018320

Access comprehensive regulatory information for ICU Medical Chemoclave Transfer system in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018320 and owned by ICU Medical Inc.. The device was registered on July 04, 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
DE0018320
ICU Medical Chemoclave Transfer system
HSA Registration Number: DE0018320
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Product Description

The intended use is for the preparation and patient administration of cytotoxic medications.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018320
Registration Date
July 04, 2016
Change Notification Approval Date
May 19, 2022
Retention Due Date
July 03, 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)
9 cm (3.5") Appx 1.3 ml, Bag Spike Adapter w/Vented Cap 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros™, Hanger 14" PUR Add-On Set w/Non-Vented Spike, Spiros®, Vented Cap 14" Add-On Set w/2 Spiros®, Vented Cap Bag Spike w/Clave® Additive Port, Clave®
Model Identifier(s)
011-CH3711 CH3020 CH3444 CH3445 CH3493