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Singapore HSA registration DE0501065

Leica Microsystems EnFocus OCT

Singapore flagSingapore·CLASS B·Leica Microsystems NC, Inc.·Registered January 04, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0501065
Registration Date
January 04, 2018
Change Notification Approval Date
May 05, 2020
Retention Due Date
January 03, 2026
Product description
The Bioptigen 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 is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.
Product Owner
Name
Leica Microsystems NC, Inc.
Short Name
Leica Microsystems NC, Inc.
Address
4222 Emperor Boulevard, Suite 390, North Carolina, UNITED STATES
Registrant
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
Name
LEICA INSTRUMENTS (SINGAPORE) PTE LIMITED LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
Model Name(s)
EnFocus C2300 VHR SDOIS System, 230V EnFocus C4400 HR SDOIS System, 230V
Model Identifier(s)
EnFocus 2300 EnFocus 4400
About this record

Access comprehensive regulatory information for Leica Microsystems EnFocus 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 DE0501065 and owned by Leica Microsystems NC, Inc.. The device was registered on January 04, 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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