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Osstem SM3 - HSA Registration DE0508599

Access comprehensive regulatory information for Osstem SM3 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508599 and owned by Osstem Implant Co., Ltd.. The device was registered on October 25, 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 B
DE0508599
Osstem SM3
HSA Registration Number: DE0508599
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Product Description

Osstem SM3 is intended for use in dental oral surgery by qualified personnel.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508599
Registration Date
October 25, 2023
Retention Due Date
October 24, 2025
Product Owner
Short Name
Osstem Implant Co., Ltd.
Address
3, Magokjungang 12-ro, Gangseo-Gu, Seoul, KOREA, REPUBLIC OF
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Model Information
Model Name(s)
S200EL Y-Connector SL SM3 FC-78 Irrigation tube
Model Identifier(s)
C1003009 C823752 E1023008 U1095003 Z1102001 Z263001