EU → North America Device Access

Merck Millipore Ltd

IE-MF-000003997 · Ireland · Co. Cork

Merck Millipore Ltd is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa49

Most frequent device types declared: Amicon, Centrifree, OEM980903, SLGVGSK33, SLHA02510.

Among these devices, 44 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 61 declared devices.

Catalogue references include OEM980903, SLHA02510, SLHVM33RS, SLMPL25SS, SLVV033RS, SPGS0250P.

European nomenclature codes declared: A04010101, W0580, F9099, A04010199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMerck Millipore Ltd. (IE) · FDA 8020892
Devices in EUDAMED61
Country of registrationIreland

Device-level evidence

Devices with a numeric GTIN61
Found in the U.S. device database38
Share62.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMERCK MILLIPORE LTD.

What it holds in Canada

Licences on record4
Currently active0
Class 2 devices4
First licensed1999-06-14

Licence types: Device Family (2), Single Device (2).

Licensed under: CATHIVEX VENTED I.V. FILTER UNIT, DUALEX TRANSDUCER PROTECTOR UNIT, MILLEX SYRINGE DRIVEN FILTER UNIT, MILLEX VIAL VENT UNIT.

North American profile: Both markets. Merck Millipore Ltd is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
40563issued2031-07-06

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