Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031600052

FEI Number

3031600052

Entity Name

OEM DEVELOPMENT

City/State/Country

SAINT BARTHELEMY D ANJOU Maine-et-Loire, FR

Establishment Address

39 BVD de la romanerie, SAINT BARTHELEMY D ANJOU Maine-et-Loire 49124, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OEM Developement (Owner Number: 10091097)

Owner / Operator Contact Address

39 Boulevard de la romanerie, Saint Barthélémy d'anjou, FR-49 49124, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RM4 KIDNEY PERFUSION SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2024-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

OEM Developement

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

View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031600052. Last updated year: 2026. Please use registration number 3031600052 when referencing this establishment in official correspondence.