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amg International QualiMed Unity-B Percutaneous Balloon Expandable Biodegradable Biliary Stent System - HSA Registration DE0508708

Access comprehensive regulatory information for amg International QualiMed Unity-B Percutaneous Balloon Expandable Biodegradable Biliary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508708 and owned by amg International GmbH. The device was registered on November 30, 2023.

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
DE0508708
amg International QualiMed Unity-B Percutaneous Balloon Expandable Biodegradable Biliary Stent System
HSA Registration Number: DE0508708
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Product Description

The UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System is used to drain obstructed bile ducts.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508708
Registration Date
November 30, 2023
Retention Due Date
November 29, 2025
Product Owner
Short Name
amg International GmbH
Address
Boschstraße 16,, 21423 Winsen (Luhe),, Germany, GERMANY
Registrant
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Importer
Address
12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516
Model Information
Model Name(s)
UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System UNITY-B Percutaneous Biodegradable Balloon Expandable Biliary Stent System
Model Identifier(s)
08 MBXb 08057A 08 MBXb 09057A 08 MBXb 10057A 12 MBXb 08057A 12 MBXb 09057A 12 MBXb 10057A 15 MBXb 08057A 15 MBXb 09057A 15 MBXb 10057A