EU → North America Device Access

LimFlow SA

FR-MF-000011529 · France · Paris

LimFlow SA is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb16
Class IIa6

Most frequent device types declared: AC-CE-21, RGS-xxxx-CE-24, SGx-xxxxx-CE-21, VC-CE-21, VT-CE-21.

Among these devices, 22 are declared sterile, 16 implantable.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include RGS-35060-CE-24, RGS-40060-CE-24, RGS-55150-CE-24, SGH-40060-CE-21, SGH-55100-CE-21, SGP-40060-CE-21.

European nomenclature codes declared: P0704020299, C01901901, C0199, C010102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLimFlow Inc. (US) · FDA 3023527320
Devices in EUDAMED22
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN22
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. LimFlow SA is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000261596issued2028-10-26
1000261582issued2028-11-27

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