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Singapore HSA registration DE0508442

Leica Microsystems EnFocus 2300 Integrated OCT System

Singapore flagSingapore·CLASS B·Leica Microsystems NC, Inc.·Registered August 29, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0508442
Registration Date
August 29, 2023
Change Notification Approval Date
May 15, 2025
Retention Due Date
August 28, 2025
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
Name
Leica Microsystems NC, Inc.
Short Name
Leica Microsystems NC, Inc.
Address
4222 Emperor Boulevard, Suite 390, Durham, NC 27703, UNITED STATES
Registrant
Name
Leica Instruments (Singapore) 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 2300 Integrated OCT System (900C23550V5)
Model Identifier(s)
9070-10100
About this record

Access comprehensive regulatory information for Leica Microsystems EnFocus 2300 Integrated OCT 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 DE0508442 and owned by Leica Microsystems NC, Inc.. The device was registered on August 29, 2023.

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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