LEICA MICROSYSTEMS (SCHWEIZ) AG

FDA Device Registration & Listing · HEERBRUGG Sankt Gallen, CH · Registration 3003974370

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
3003974370
FEI Number
3003974370
Entity Name
LEICA MICROSYSTEMS (SCHWEIZ) AG
City/State/Country
HEERBRUGG Sankt Gallen, CH
Establishment Address
MAX SCHMIDHEINY-STRASSE 201, HEERBRUGG Sankt Gallen 9435, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K181537
PMA Number
N/A

All Registered Proprietary Names

Leica FL560 Leica FL560 Procedure Kit 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 Leica FL800 Leica FL400 Leica FL800 ULT Leica FL800 GLOW800

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 2017-07-14
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 2017-05-08
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2017-05-08
QFX Diagnostic Neurosurgical Microscope Filter Neurology Class 2 882.4950 2019-04-08
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-05-08
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2017-05-08
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2018-09-13

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
1000204638 LEICA INSTRUMENTS (SINGAPORE) PTE LTD. SINGAPORE South West, SG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003974370. Last updated year: 2026. Please use registration number 3003974370 when referencing this establishment in official correspondence.
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