Skip to content

Scanmed, LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000011107 FEI 1000158431

Scanmed, LLC is a medical device manufacturer based in the United States, with 47 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 14 Nov 2026.

Devices
47
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 46
  • EUDAMED 2
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 45
  • EU Class IIa 2
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000011107
  • FDA FEI 1000158431
  • DUNS 080151631

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Emergo Europe B.V.NL

What Scanmed, LLC makes

ScanMed, LLC manufactures radio-frequency MRI system coils. Their product portfolio includes specialized imaging components such as elbow, knee, foot, blanket, and long bone coils, as well as pediatric head and spine arrays.

These medical devices are categorized as Class II and Class IIa products. The company is based in the United States, and their devices are listed in the FDA 510(k), FDA UDI, and EUDAMED regulatory databases.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue47

Newest first, rows 1-47 of 47

Search and filter all 47 devices
Skip device list

Rows 1-47 of 47

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000011107
FDA FEI number
1000158431
DUNS number
080151631
EUDAMED status
Active
EUDAMED registered name
ScanMed LLC
EUDAMED abbreviated name
ScanMed
Registered address
9840, SOUTH 140 ST, 68138, Omaha, United States
Phone
1-402-934-2650
PRRC contact
CARLEE SEEBA(public in EUDAMED)

Frequently asked questions

How many devices does SCANMED, LLC have in the registry?

The registry currently lists 47 devices for SCANMED, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list SCANMED, LLC's devices?

Among its 47 most recently registered devices, SCANMED, LLC has devices listed in EUDAMED (2 devices), FDA 510(k) (1 device) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SCANMED, LLC's devices fall under?

Among its 47 most recently registered devices, the classes recorded for SCANMED, LLC's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from SCANMED, LLC in the registry?

The most recently registered devices listed for SCANMED, LLC include ScanMed Elbow Coil 316GE1501, ScanMed Knee/Foot Coil 116GE1501, ScanMed Blanket Coil 516GE3001 and ScanMed Long Bone (M) Coil 168GE3001.

Generated automatically from registry data and not verified by a human reviewer.