FDA.reportPublic FDA data

LEICA MICROSYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14233373000210133LEICA MICROSYSTEMS, INC.1Y2026-01-0110 Parkway North Blvd. Suite 300 Deerfield IL US 60015
30038939523003893952LEICA MICROSYSTEMS CMS GMBH1N2026-01-01ERNST-LEITZ-STRASSE 17-37 WETZLAR Hesse DE 35578
30066109133006610913LEICA MICROSYSTEMS LTD SHANGHAI1N2026-01-01Floor 1, 2, 3A, 4A, and 6, Building T20-1 & Room 301 Building T20-5, 258 Jinzang Road China (Shanghai) Pilot Free Trade Zone CN 201206
30068096953006809695Leica Microsystems NC, Inc.1N2026-01-014222 Emperor Blvd Suite 390 Durham NC US 27703
14233373000210133LEICA MICROSYSTEMS, INC.1Y2020-04-251700 Leider Ln Buffalo Grove IL US 60089
30068096953006809695Leica Microsystems NC, Inc.1N2020-04-254222 Emperor Blvd Suite 390 Durham NC US 27703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07630003568707M822 Optics Carrier - M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40+1(847)8213502Andrew.Suchomski@leica-microsystems.com
07630003568707M822 Optics Carrier - M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40+1(984)7105152Iris.Pohl@leica-microsystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2827821998945142K162783EnFocus 2300, EnFocus 4400OBO2016-12-09
2827821181537441K150722EnFocus 2300, EnFocus 4400HLI2015-12-02
881081520719325K150722EnFocus 2300, EnFocus 4400HLI2015-12-02
881081791953058K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)HLI2012-05-11
881081896629300K063343BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEMHLI2006-12-13
2073761120308909
2073901357057235
2073901392062066
2073761403731565
2073761504718450
2073761726147003
2073761746109495
2073761826227213
2073761845484678
2073901904457887
2073761954012587

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HLI42015-12-02
OBO12016-12-09

PMN#

GLOW800

2018-09-07

Leica Microsystems (Schweiz) AG

GUDID#

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