LEICA INSTRUMENTS (SINGAPORE) PTE LTD.

FDA Device Registration & Listing · SINGAPORE South West, SG · Registration 1000204638

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000204638
FEI Number
1000204638
Entity Name
LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
City/State/Country
SINGAPORE South West, SG
Establishment Address
15 TUKANG INNOVATION DRIVE, SINGAPORE South West 618299, SG
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Leica Microsystems CMS GmbH (Owner Number: 10054809)
Owner / Operator Contact Address
Ernst-Leitz-Strasse 17-37, Wetzlar, DE-HE 35578, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Leica FL800 Leica M530 OHX Leica M320 W12 Leica M320 C12 Leica M320 TC12 Leica Wireless Footswitch, 12 Functions Leica M525 F20 Leica M320 LW12 Leica M320 TP12 Leica M320 FP12 Leica Wireless Footswitch, 14 Functions Leica M320 F12 Surgical Microscope Air Removal System (SMARS) PROvido ARveo 8 MyVeo ARveo 8x Leica FL800 Leica ToricEyePiece PROVEO 8 F42 Leica RUV800 WD175 Leica M822 CT40 Leica M822 F20 Leica Wireless Footswitch, 12 Functions Leica Wireless Footswitch, 14 Functions Leica M822 F40 Leica RUV800 WD200 PROVEO 8 CT42 PROVEO 8x GLOW800 Leica FL800 ULT Leica FL400

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-05-08
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2017-05-08
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2017-05-08
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-05-08
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2017-05-08
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2018-09-13
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-05-08
QFX Diagnostic Neurosurgical Microscope Filter Neurology Class 2 882.4950 2019-04-08

Official Correspondent

Roland Jehle

US Agent Details

Iris Pohl Business: LEICA MICROSYSTEMS NC, INC. Email: Iris.Pohl@leica-microsystems.com Phone: (919) 5951274

Related Public Records

Same Entity

Leica Microsystems CMS GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006809695 Leica Microsystems NC, Inc. Durham, NC, US
3003893952 LEICA MICROSYSTEMS CMS GMBH WETZLAR Hesse, DE
3003974370 LEICA MICROSYSTEMS (SCHWEIZ) AG HEERBRUGG Sankt Gallen, CH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000204638. Last updated year: 2026. Please use registration number 1000204638 when referencing this establishment in official correspondence.
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