Singapore HSA registration DE0506185
Venus Concept ARTAS iX System
Singapore·CLASS B·Venus Concept, Inc.·Registered September 17, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0506185
- Registration Date
- September 17, 2021
- Change Notification Approval Date
- November 27, 2024
- Retention Due Date
- September 16, 2025
Product description
The ARTAS iX System is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS iX System is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation; creating recipient sites; and implanting harvested hair follicles
Product Owner
- Short Name
- Venus Concept, Inc.
- Address
- 1800 Bering Drive, San Jose, CA 95112, UNITED STATES
Registrant
- Address
- 1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
- Address
- 19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Model information
- Model Name(s)
- Disposable Kit, 18G 2 Prong, Sterile and Non-Sterile, iX Disposable Kit, 19G 2 Prong, Sterile and Non-Sterile, iX Disposable Kit, 18G 4 Prong, Sterile and Non-Sterile, iX Disposable Kit, 19G 4 Prong, Sterile and Non-Sterile, iX Disposable Kit, 18G 2 Prong, Sterile and Non-Sterile, iX (S) Disposable Kit, 19G 2 Prong, Sterile and Non-Sterile, iX (S) Disposable Kit, 18G 4 Prong, Sterile and Non-Sterile, iX (S) Disposable Kit, 19G 4 Prong, Sterile and Non-Sterile, iX (S) ARTAS iX Site Making & Implantation Kit, 18G ARTAS iX Site Making & Implantation Kit, 19G ARTAS iX System ARTAS iX Reusable Kit, Harvesting
- Model Identifier(s)
- FP-102766 FP-102767 FP-102768 FP-102769 FP-102773 FP-102774 FP-102775 FP-102776 FP-102777 FP-102778 FP-45000 FRU-102780
About this record
Access comprehensive regulatory information for Venus Concept ARTAS iX System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506185 and owned by Venus Concept, Inc.. The device was registered on September 17, 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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