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MegaGen N2 Dental Units - HSA Registration DE0507535

Access comprehensive regulatory information for MegaGen N2 Dental Units in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507535 and owned by MegaGen Implant Co., Ltd.. The device was registered on November 24, 2022.

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
DE0507535
MegaGen N2 Dental Units
HSA Registration Number: DE0507535
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Product Description

N2 is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic Environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507535
Registration Date
November 24, 2022
Retention Due Date
November 23, 2025
Product Owner
Short Name
MegaGen Implant Co., Ltd.
Address
45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, KOREA, REPUBLIC OF
Registrant
Address
10 UBI CRESCENT, UBI TECHPARK, #04-66, SINGAPORE 408564
Importer
Address
13 UBI CRESCENT, #03-00, SINGAPORE 408574
Model Information
Model Name(s)
3-way syringe Tip Cart Table Foot Switch N2 (Cart A Type) N2 (Cart B Type) N2 (Mount A Type) N2 (Mount B Type)
Model Identifier(s)
3-way syringe Cart Table (Components of Dental Unit) Foot Switch (Components of Dental Unit) N2 (Cart A Type) N2 (Cart B Type) N2 (Mount A Type) N2 (Mount B Type)