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Singapore HSA registration DE0510593

Megagen Bone Matrix 1

Singapore flagSingapore·CLASS D·MegaGen Implant Co., Ltd.·Registered April 14, 2025
Device classification
Device Class
CLASS D
Medical Speciality Area
Dental
Registration information
Registration Number
DE0510593
Registration Date
April 14, 2025
Retention Due Date
April 13, 2026
Product description
Bone Matrix I is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bone Matrix I can be used with autograft as a bone graft extender. Typical uses include: - Periodontal/Infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Sinus lifts
Product Owner
Name
MegaGen Implant Co., Ltd.
Short Name
MegaGen Implant Co., Ltd.
Address
45, Secheon-ro 7-gil, Dasa-eup,, Dalseong-gun, Daegu 42921, KOREA, REPUBLIC OF
Registrant
Name
megagen singapore pte ltd
Address
10 UBI CRESCENT, UBI TECHPARK, #04-66, SINGAPORE 408564
Importer
Name
MEGAGEN SINGAPORE PTE LTD
Address
13 UBI CRESCENT, #03-00, SINGAPORE 408574
Model information
Model Name(s)
Bone Matrix I Bone Matrix I Bone Matrix I Bone Matrix I Bone Matrix I Bone Matrix I Bone Matrix I Bone Matrix I
Model Identifier(s)
BM10601 BM10602 BM10605 BM10610 BM10801 BM10802 BM10805 BM10810
About this record

Access comprehensive regulatory information for Megagen Bone Matrix 1 in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510593 and owned by MegaGen Implant Co., Ltd.. The device was registered on April 14, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D