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Liebel-Flarsheim Company, LLC

United States·US-MF-000002605

Last updated May 23, 2026

What Liebel-Flarsheim Company, LLC makes

Liebel-Flarsheim Company, LLC manufactures a range of stationary, line‑powered injection systems for delivering contrast media in angiography, CT, and MRI procedures, as well as related accessories such as angiography kits, angiographic syringes, general‑purpose fluid transfer sets, radiographic procedure tubing, and a multi‑purpose warming cabinet.

The devices are classified as Class I, Class II, and Class IIb and are listed in the FDA UDI database and the EU’s Eudamed registry; the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Liebel-Flarsheim Company, LLC manufacture?

Liebel-Flarsheim Company, LLC manufactures stationary, line-powered injection systems for delivering contrast media in angiography, CT, and MRI procedures, along with related accessories like angiography kits, angiographic syringes, fluid transfer sets, radiographic procedure tubing, and a multi-purpose warming cabinet.

Where is Liebel-Flarsheim Company, LLC based?

Liebel-Flarsheim Company, LLC is based in the United States, as indicated by the country designation in the device data.

Which regulatory registries list Liebel-Flarsheim's devices?

Liebel-Flarsheim's devices are listed in the FDA UDI database and the EU's Eudamed registry, as specified in the device data.

How are Liebel-Flarsheim's devices classified?

Liebel-Flarsheim's devices are classified as Class I, Class II, and Class IIb, which reflects their varying levels of risk and regulatory control requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 2111, E. Galbraith Road, Cincinnati, United States
Website: guerbet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jacob Miller
EUDAMED SRN: US-MF-000002605
FDA FEI Number: —
DUNS Number: —

Catalogue (128)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Lf	844023P	FDA UDI	Class II	Unknown
Lf	844023	FDA UDI	Class II	Active
Lf	849002C	FDA UDI	Class II	Active
Lf	600150	FDA UDI	Class I	Active
Lf	800114	FDA UDI	Class II	Active
Lf	849001C	FDA UDI	Class II	Active
Lf	700539	FDA UDI	Class II	Unknown
Lf	601195	FDA UDI	Class II	Active
Lf	810555	FDA UDI	Class II	Active
Lf	705560	FDA UDI	Class II	Unknown
Lf	333144S	FDA UDI	Class I	Unknown
Lf	600151	FDA UDI	Class I	Active
Lf	800099	FDA UDI	Class II	Active
Lf	801106	FDA UDI	Class II	Active
Lf	814002C	FDA UDI	Class II	Active
Lf	414220S	FDA UDI	Class I	Unknown
Lf	601277	FDA UDI	Class II	Unknown
Lf	900681	FDA UDI	Class I	Active
Lf	335825	FDA UDI	Class I	Unknown
Lf	DE844005	FDA UDI	Class II	Unknown
Lf	900608	FDA UDI	Class I	Active
Lf	DL802001	FDA UDI	Class II	Unknown
Lf	DS814001	FDA UDI	Class II	Unknown
Lf	9898 012 20046	FDA UDI	Class I	Active
Lf	900105	FDA UDI	Class II	Active
Lf	405040	FDA UDI	Class I	Unknown
Lf	DL844003	FDA UDI	Class II	Unknown
Lf	333105	FDA UDI	Class I	Unknown
Lf	DL844001	FDA UDI	Class II	Unknown
Lf	600269	FDA UDI	Class II	Active
Lf	241079S	FDA UDI	Class I	Active
Lf	900006C	FDA UDI	Class II	Active
Lf	844022P	FDA UDI	Class II	Unknown
Lf	600172	FDA UDI	Class II	Unknown
Lf	801801	FDA UDI	Class II	Active
Lf	802617	FDA UDI	Class I	Active
Lf	800096P	FDA UDI	Class II	Unknown
Lf	900680	FDA UDI	Class I	Active
Lf	402350	FDA UDI	Class I	Unknown
Lf	705559	FDA UDI	Class II	Unknown
Lf	900606	FDA UDI	Class I	Active
Lf	847003	FDA UDI	Class II	Active
Lf	844210	FDA UDI	Class II	Active
Lf	700559	FDA UDI	Class II	Unknown
Lf	801800	FDA UDI	Class II	Active
Lf	814005C	FDA UDI	Class II	Active
Lf	900209	FDA UDI	Class II	Active
Lf	404071	FDA UDI	Class I	Unknown
Lf	900001C	FDA UDI	Class II	Active
Lf	814004C	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Guerbet FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 11, 2021	Z-1992-2021	—	terminated	Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Feb 27, 2017	Z-2833-2018	—	terminated	Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
Feb 27, 2017	Z-2834-2018	—	terminated	Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.