Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611902

FEI Number

3002806589

Entity Name

Fenwal France S.A.S.

City/State/Country

Lacs Indre, FR

Establishment Address

Etaille, Lacs Indre 36400, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Fresenius Kabi AG (Owner Number: 9027285)

Owner / Operator Contact Address

Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INTERCEPT BLOOD SYSTEM FOR PLATELETS INTERCEPT BLOOD SYSTEM FOR PLASMA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PJF	Illuminator System For Blood Products	Unknown	Class 3	N/A	2015-01-02
PJF	Illuminator System For Blood Products	Unknown	Class 3	N/A	2015-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

Rhoda Lynn Valera Email: rhoda.valera@fresenius-kabi.com Phone: (847) 5502929

Related Public Records

Same Entity

Fresenius Kabi AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014732157	Fresenius Kabi USA, LLC	North Andover, MA, US
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
9681819	FRESENIUS KABI DEUTSCHLAND GMBH	BAD HERSFELD Hesse, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3005778453	FRESENIUS KABI WARRENDALE	WARRENDALE, PA, US

Similar Registrations

Registration Number	Establishment Name	Location
1219029	NOVA BIOMEDICAL CORPORATION	WALTHAM, MA, US
3007170494	Cerus Europe BV	Amersfoort Utrecht, NL
3003925919	CERUS CORPORATION	Concord, CA, US
1058584	Sterigenics US LLC	Charlotte, NC, US
3031365458	WOMED SAS	Montpellier Herault, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611902. Last updated year: 2026. Please use registration number 9611902 when referencing this establishment in official correspondence.