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Cook Approach Hydro ST Microwire Guide - HSA Registration DE0009648

Access comprehensive regulatory information for Cook Approach Hydro ST Microwire Guide in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009648 and owned by Cook Medical Incorporated. The device was registered on August 29, 2012.

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
DE0009648
Cook Approach Hydro ST Microwire Guide
HSA Registration Number: DE0009648
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Product Description

Intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0009648
Registration Date
August 29, 2012
Change Notification Approval Date
October 28, 2021
Retention Due Date
August 28, 2025
Product Owner
Short Name
Cook
Address
1025 Acuff Road,, P.O. Box 4195, Bloomington, IN 47402-4195, UNITED STATES
Registrant
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model Information
Model Name(s)
Approach Hydro ST Micro Wire Guide with Hydrophilic Coating Approach Hydro ST Micro Wire Guide with Hydrophilic Coating Approach Hydro ST Micro Wire Guide with Hydrophilic Coating
Model Identifier(s)
HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST