Pure Global
Singapore HSA registration DE0017258

Leica Microsystems FL800 ULT

Singapore flagSingapore·CLASS B·Leica Microsystems (Schweiz) AG·Registered June 18, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration information
Registration Number
DE0017258
Registration Date
June 18, 2015
Change Notification Approval Date
May 12, 2024
Retention Due Date
June 17, 2025
Product description
The Leica FL800 ULT is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area, blood flow of the coronary vascular and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery
Product Owner
Name
Leica Microsystems (Schweiz) AG
Short Name
Leica Microsystems (Schweiz) AG
Address
Max Schmidheinly-Strasse 201, SWITZERLAND
Registrant
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
Model Name(s)
Leica FL800 ULT Leica M530 OH6 Leica M530 OHX
Model Identifier(s)
10448761 M530 OH6 M530 OHX
About this record

Access comprehensive regulatory information for Leica Microsystems FL800 ULT in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017258 and owned by Leica Microsystems (Schweiz) AG. The device was registered on June 18, 2015.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B