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Azena Gemini 810+980 Diode Laser - HSA Registration DE0506276

Access comprehensive regulatory information for Azena Gemini 810+980 Diode Laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506276 and owned by Azena Medical, LLC. The device was registered on October 11, 2021.

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 C
DE0506276
Azena Gemini 810+980 Diode Laser
HSA Registration Number: DE0506276
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Product Description

The GEMINI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, haemostasis and treatment (including pain relief using photobiomodulation) of oral soft tissue

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506276
Registration Date
October 11, 2021
Retention Due Date
October 10, 2025
Product Owner
Short Name
Azena Medical, LLC
Address
30212 Cirtus Cir., Ste 180, CA 94598, UNITED STATES
Registrant
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
Address
7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Model Information
Model Name(s)
Gemini Laser Kit Gemini Power supply Gemini Foot pedal Gemini 5mm tips Gemini 7mm tips Handpiece Shell Gemini PBM adapter kit Disposable PBM Spacer Tips
Model Identifier(s)
8990 8991 8992 8993 8994 8996 8998 8999