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MC3 Opus Vascular Access Kit - HSA Registration DE0510233

Access comprehensive regulatory information for MC3 Opus Vascular Access Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510233 and owned by MC3, Inc. The device was registered on January 13, 2025.

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
DE0510233
MC3 Opus Vascular Access Kit
HSA Registration Number: DE0510233
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Product Description

The vascular access kit is intended for single use by a trained physician to assist in vessel cannulation.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0510233
Registration Date
January 13, 2025
Retention Due Date
January 12, 2026
Product Owner
Short Name
MC3, Inc
Address
2555 Bishop Circle West, Dexter, MI 48130, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Opusโ„ข Vascular Access Kit
Model Identifier(s)
21030