Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010765841

FEI Number

3010765841

Entity Name

INSTITUT GEORGES LOPEZ

City/State/Country

Lissieu Auvergne-Rhone-Alpes, FR

Establishment Address

Parc tertiaire du Bois Dieu, 1 allee des chevreuils, Lissieu Auvergne-Rhone-Alpes 69380, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Institut Georges Lopez (Owner Number: 10051357)

Owner / Operator Contact Address

Parc tertiaire du Bois Dieu, 1 allee des chevreuils, Lissieu, FR-ARA 69380, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PERF-GEN Pulsatile Perfusion Solution Waters IGL Pulsatile Perfusion Solution Celsior Cold Flushing, Storage and Transportation Solution for Hearts PCAN RM4 PCL P2PC PEL Perfusion Clamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDL	Set, Perfusion, Kidney, Disposable	Gastroenterology, Urology	Class 2	876.5880	2022-06-20
MSB	System And Accessories, Isolated Heart, Transport And Preservation	Gastroenterology, Urology	Class 2	876.5880	2016-03-07
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2022-11-04
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	2023-06-01

Official Correspondent

Matthieu PROUTEAU

US Agent Details

Ashley BANKS Business: Waters Medical Systems LLC Email: abanks@wtrs.com Phone: (507) 2523729

Related Public Records

Same Entity

Institut Georges Lopez

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024820181	INSTITUT GEORGES LOPEZ	ST LAURENT DE CHAMOUSSET Rhone, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25

Similar Registrations

Registration Number	Establishment Name	Location
3011421726	Marizyme, Inc.	West Palm Bch, FL, US
3024820181	INSTITUT GEORGES LOPEZ	ST LAURENT DE CHAMOUSSET Rhone, FR
1067143	BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.	Peachtree Corners, GA, US
3020224798	LIFECYCLE BIOTECHNOLOGIES, LLC	Cleburne, TX, US
3031884833	Bridge to Life Ltd	Duluth, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010765841. Last updated year: 2026. Please use registration number 3010765841 when referencing this establishment in official correspondence.