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Biosensors Chroma™ Coronary Stent System - HSA Registration DE0017973

Access comprehensive regulatory information for Biosensors Chroma™ Coronary 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 DE0017973 and owned by Biosensors Europe SA. The device was registered on March 28, 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 D
DE0017973
Biosensors Chroma™ Coronary Stent System
HSA Registration Number: DE0017973
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Product Description

The Chroma Coronary Stent System is indicated for improving coronary luminal diameter by treatment of lesions in coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm. Stents with length 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00107
HS Code
90219000
Registration Information
Registration Number
DE0017973
Registration Date
March 28, 2016
Change Notification Approval Date
December 13, 2024
Retention Due Date
March 27, 2026
Product Owner
Short Name
Biosensors
Address
Rue de Lausanne 29, 1110 Morges, SWITZERLAND
Registrant
Address
36 JALAN TUKANG, SINGAPORE 619266
Importer
Address
36 JALAN TUKANG, SINGAPORE 619266
Model Information
Model Name(s)
Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System Chroma Coronary Stent System
Model Identifier(s)
BCR-2209 BCR-2214 BCR-2219 BCR-2224 BCR-2229 BCR-2509 BCR-2514 BCR-2519 BCR-2524 BCR-2529 BCR-2533 BCR-2536 BCR-2709 BCR-2714 BCR-2719 BCR-2724 BCR-2729 BCR-2733 BCR-2736 BCR-3009 BCR-3014 BCR-3019 BCR-3024 BCR-3029 BCR-3033 BCR-3036 BCR-3509 BCR-3514 BCR-3519 BCR-3524 BCR-3529 BCR-3533 BCR-3536 BCR-4009 BCR-4014 BCR-4019 BCR-4024 BCR-4029