Singapore HSA registration DE0504115
Leica Microsystems EnFocus 2300 Integrated OCT
Singapore·CLASS B·Leica Microsystems NC, Inc.·Registered February 14, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0504115
- Registration Date
- February 14, 2020
- Change Notification Approval Date
- March 12, 2021
- Retention Due Date
- February 13, 2026
Product description
The EnFocus OCT device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocus OCT system is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. The EnFocus OCT system is indicated for use on patient populations from premature and neonatal infants to adult. The EnFocus OCT system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.
Product Owner
- Short Name
- Leica Microsystems NC, Inc.
- Address
- 4222 Emperor Boulevard, Suite 390, Durham, NC 27703, UNITED STATES
Registrant
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
- Model Name(s)
- EnFocus 2300 Integrated OCT System
- Model Identifier(s)
- 9070-10088
About this record
Access comprehensive regulatory information for Leica Microsystems EnFocus 2300 Integrated OCT in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504115 and owned by Leica Microsystems NC, Inc.. The device was registered on February 14, 2020.
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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