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Osstem K5 Dental Unit and Chair - HSA Registration DE0509045

Access comprehensive regulatory information for Osstem K5 Dental Unit and Chair in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509045 and owned by Osstem Implant Co., Ltd.. The device was registered on March 12, 2024.

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
DE0509045
Osstem K5 Dental Unit and Chair
HSA Registration Number: DE0509045
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Product Description

Intended for use on humans in the field of dentistry and may only be used by trained dental professionals.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0509045
Registration Date
March 12, 2024
Retention Due Date
March 11, 2026
Product Owner
Short Name
Osstem Implant Co., Ltd.
Address
192, Haebong-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15428, 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)
K5 Cart K5 Mount Osstem K5 Foot Control Osstem K5 Foot Control
Model Identifier(s)
K5 Cart K5 Mount K5FB-0 K5FB-1