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KermaX-plus

FDA UDI

Class I (US FDA UDI)

by IBA Dosimetry GmbH

Identity

Trade Name
KermaX-plus FDA UDI
Generic Name
Diagnostic x-ray system quality assurance device FDA UDI
Device Name
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time. FDA UDI
Model / Reference
1 FDA UDI
Description
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time. FDA UDI

Identifiers

Catalog Number
120-126 TINO FDA UDI
Primary DI / UDI-DI
EIBA120126TINO0 FDA UDI
FDA Product Code
LHO FDA UDI
GMDN Term
Diagnostic x-ray system quality assurance device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1940 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray system quality assurance device

KermaX-plus by IBA Dosimetry GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray system quality assurance device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IBA Dosimetry GmbH

Sources (1)

  • FDA UDI 49f328ae-5958-434d-b63d-d177ec8afb35 35 fields · synced Jun 8, 2026