Is this your brand? Sign in to claim ownership.

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 1 of 3

Device	Model / Reference	Registries	Class	Status
Lf	302050	FDA UDI	Class II	Active
Lf	800096	FDA UDI	Class II	Active
Lf	900003	FDA UDI	Class II	Active
Lf	814001C	FDA UDI	Class II	Active
Lf	900613	FDA UDI	Class I	Active
Lf	802545	FDA UDI	Class I	Active
Lf	844010	FDA UDI	Class II	Active
Lf	844500	FDA UDI	Class I	Active
Lf	900103P	FDA UDI	Class II	Unknown
Lf	900561	FDA UDI	Class I	Active
Lf	403095	FDA UDI	Class I	Unknown
Lf	335563	FDA UDI	Class I	Unknown
Lf	844200	FDA UDI	Class II	Active
Lf	844022	FDA UDI	Class II	Active
Lf	334634	FDA UDI	Class I	Unknown
Lf	900008	FDA UDI	Class II	Active
Lf	DS900006	FDA UDI	Class II	Unknown
Lf	802850	FDA UDI	Class I	Active
Lf	333138	FDA UDI	Class I	Unknown
Lf	802620	FDA UDI	Class II	Active
Lf	601577	FDA UDI	Class I	Active
Lf	DL900001	FDA UDI	Class II	Unknown
Lf	844012	FDA UDI	Class II	Active
Lf	399300	FDA UDI	Class II	Active
Lf	844011	FDA UDI	Class II	Active
Lf	700560	FDA UDI	Class II	Unknown
Lf	900208	FDA UDI	Class II	Active
Lf	DL844005	FDA UDI	Class II	Unknown
Lf	900105P	FDA UDI	Class II	Unknown
Lf	DL900006	FDA UDI	Class II	Unknown
Lf	601281	FDA UDI	Class II	Unknown
Lf	847002	FDA UDI	Class II	Active
Lf	333700	FDA UDI	Class I	Unknown
Lf	900430	FDA UDI	Class II	Active
Lf	900002	FDA UDI	Class II	Active
Lf	900211	FDA UDI	Class II	Active
Lf	900227	FDA UDI	Class II	Active
Lf	800099P	FDA UDI	Class II	Unknown
Lf	DE814001	FDA UDI	Class II	Unknown
Lf	900700	FDA UDI	Class I	Active
Lf	900607	FDA UDI	Class I	Active
Lf	DS844005	FDA UDI	Class II	Unknown
Lf	900103	FDA UDI	Class II	Active
Lf	700540	FDA UDI	Class II	Unknown
Lf	908000	FDA UDI	Class I	Active
Lf	810551	FDA UDI	Class II	Active
Lf	900570	FDA UDI	Class I	Active
Lf	802725	FDA UDI	Class I	Active
Lf	DS900001	FDA UDI	Class II	Unknown
Lf	601280	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.