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Bard SenoMark® UltraCor® Breast Tissue Marker (Biodur 108) - HSA Registration DE0500706

Access comprehensive regulatory information for Bard SenoMark® UltraCor® Breast Tissue Marker (Biodur 108) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0500706 and owned by Bard Peripheral Vascular, Inc. The device was registered on September 28, 2017.

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 D
DE0500706
Bard SenoMark® UltraCor® Breast Tissue Marker (Biodur 108)
HSA Registration Number: DE0500706
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Product Description

The breast tissue marker is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0500706
Registration Date
September 28, 2017
Change Notification Approval Date
November 29, 2024
Retention Due Date
September 27, 2026
Product Owner
Short Name
Bard
Address
1625 West 3rd Street, Tempe, AZ 85281, UNITED STATES
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
SenoMark® UltraCor® Breast Tissue Marker SenoMark® UltraCor® Breast Tissue Marker SenoMark® UltraCor® Breast Tissue Marker SenoMark® UltraCor® Breast Tissue Marker
Model Identifier(s)
SMUC10C SMUC10V SMUC13C SMUC13V