Singapore HSA registration DE0506276
Azena Gemini 810+980 Diode Laser
Singapore·CLASS C·Azena Medical, LLC·Registered October 11, 2021Device 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 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
Product Owner
- Short Name
- Azena Medical, LLC
- Address
- 30212 Cirtus Cir., Ste 180, CA 94598, UNITED STATES
Registrant
- Name
- Fondaco Pte Ltd
- Address
- 7 KAKI BUKIT ROAD 1, Eunos Techno Link, #03-06, SINGAPORE 415937
Importer
- Name
- Fondaco Pte Ltd
- 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
About this record
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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