Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612003

FEI Number

3002807666

Entity Name

MILLIPORE S.A.S

City/State/Country

MOLSHEIM Grand Est, FR

Establishment Address

39, Route Zone Industrielle de la Hardt, MOLSHEIM Grand Est 67120, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MilliporeSigma (Owner Number: 1216103)

Owner / Operator Contact Address

28820 Single Oak Drive, Temecula, CA 92590, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133004

PMA Number

N/A

All Registered Proprietary Names

Centrifree Amicon Ultra - 15 Amicon Ultra - 4 Millex-AA Millex-HA Millex-GS Millex-HP Millex-GP Millex FG Millex 33 HV Millex 33 VV Millex 33 GV Dualex Ultra TP Dualex Plus TP Dualex TP Millex - MP Filter Units Cathivex-GV Filter Units Multiscreen-HV Vented Millex-GV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	1994-06-23
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-07-20
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2011-06-29
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-07-20
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2011-07-20
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2011-06-27
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-06-28
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2015-08-26
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	1993-01-04
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2014-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Catherine Karaman Business: MilliporeSigma Email: catherine.karaman@milliporesigma.com Phone: (916) 2654660

Related Public Records

Same Entity

MilliporeSigma

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610805	MILLIPORE (UK) LTD	LIVINGSTON, W. LOTHIAN West Lothian, GB
3017212430	CELL MARQUE CORP.	Saint Louis, MO, US
1937990	SIGMA-ALDRICH MANUFACTURING, LLC-H&H	Saint Louis, MO, US
8020892	Merck Millipore Ltd.	COUNTY CORK Munster, IE
1000138378	SIGMA-ALDRICH CORP.	Saint Louis, MO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812750	Instrumentation Laboratory CO	IL 703, STAT SEPARATOR	1982-01-26

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3014290238	OMEGA BIO-TEK	Norcross, GA, US
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3009311010	Promega Biosystems Inc.	Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612003. Last updated year: 2026. Please use registration number 9612003 when referencing this establishment in official correspondence.