Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020892

FEI Number

1000532580

Entity Name

Merck Millipore Ltd.

City/State/Country

COUNTY CORK Munster, IE

Establishment Address

TULLAGREEN CARRIGTWOHILL, COUNTY CORK Munster --, IE

Establishment Type(s)

Manufacture Medical 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

K013988

PMA Number

N/A

All Registered Proprietary Names

Millex GS Millex HV Millex OR Millex GV Vented Millex AA Vented Millex GS Millex SV Millex HA (Non-sterile) Millex OR (Non-sterile) Dualex Ultra TP Dualex Plus TP Dualex TP Multiscreen-HV Vented Millex-GV Millex FG Centrifree Amicon Ultra - 15 Amicon Ultra - 4 Millex 33 HV Millex 33 VV Millex 33 GV Millex - MP Filter Units Millex-AA Millex-HA Millex-GS Millex-HP Millex-GP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-06-29
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2011-06-27
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
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2011-06-29
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	2011-07-20
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-06-28
BSN	Filter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5130	2011-07-20

Official Correspondent

No official correspondent registered.

US Agent Details

Catherine Karaman Business: MilliporeSigma Email: Catherine.karaman@milliporesigma.com Phone: (951) 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
1000138378	SIGMA-ALDRICH CORP.	Saint Louis, MO, US
3009432145	EMD MILLIPORE CORPORATION	Burlington, MA, US

Related 510(k) Records

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

Similar Registrations

Registration Number	Establishment Name	Location
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
3010173425	Synergy Health Westport Ltd	Westport Mayo, IE
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE
9612003	MILLIPORE S.A.S	MOLSHEIM Grand Est, FR
3010082909	Emsere, Inc.	Peachtree City, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020892. Last updated year: 2026. Please use registration number 8020892 when referencing this establishment in official correspondence.