Singapore HSA registration DE0502550
Lumenis VersaCut Tissue Morcellator
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0502550
- Registration Date
- December 19, 2018
- Change Notification Approval Date
- February 13, 2025
- Retention Due Date
- December 18, 2025
Product description
The VersaCut Tissue Morcellator is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
Product Owner
- Name
- Lumenis Ltd
- Short Name
- Lumenis Ltd
- Address
- Yokneam Industrial Park, Hakidma Street, 6. P.O.B. 240, Yokneam 2069204, ISRAEL
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model information
- Model Name(s)
- VersaCutTM Blade Set VersaCutTM Handpiece, Replacement VersaCutTM Control Unit VersaCutTM Tissue Morcellator System VersaCutTM Handpiece Aspiration Disposables kit, 6 pack INT Aspiration Disposables kit, 1 Pack INT Aspiration Tube, for USA
- Model Identifier(s)
- 0636-454-01 0637-201-01 0637-202-01 0637-245-01 0644-000-01 AC-1141650 AC-1141930 AC-2003592
About this record
Access comprehensive regulatory information for Lumenis VersaCut Tissue Morcellator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502550 and owned by Lumenis Ltd. The device was registered on December 19, 2018.
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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