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Heraeus Medical Bard SOLO™ FLEX Hybrid Guidewire - HSA Registration DE0018614

Access comprehensive regulatory information for Heraeus Medical Bard SOLO™ FLEX Hybrid Guidewire in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018614 and owned by Heraeus Medical Components, LLC. The device was registered on October 03, 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
DE0018614
Heraeus Medical Bard SOLO™ FLEX Hybrid Guidewire
HSA Registration Number: DE0018614
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Product Description

Intended for use in facilitating the placement of endourological instruments during diagnostic or interventional procedures. This guidewire is not intended for coronary artery, vascular or neurological use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0018614
Registration Date
October 03, 2016
Change Notification Approval Date
July 04, 2022
Retention Due Date
October 02, 2025
Product Owner
Short Name
Heraeus Medical Components, LLC
Address
5030 Centerville Road, St Paul, Minnesota, 55127, UNITED STATES
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #33-07/08, SINGAPORE 079903 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
SOLO™ FLEX Hybrid Guidewire SOLO™ FLEX Hybrid Guidewire SOLO™ FLEX Hybrid Guidewire SOLO™ FLEX Hybrid Guidewire
Model Identifier(s)
HW35FA HW35FS HW38FA HW38FS