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Omnera 400a

FDA UDI

Class II (US FDA UDI)

by Arcoma AB

Identity

Trade Name
OMNERA 400A FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography. FDA UDI
Model / Reference
0072 FDA UDI
Description
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography. FDA UDI

Identifiers

Primary DI / UDI-DI
07350008750012 FDA UDI
FDA Product Code
MQB FDA UDI
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 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: Stationary basic diagnostic x-ray system, digital

Omnera 400a by Arcoma AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arcoma AB

Sources (1)

  • FDA UDI 0d310730-f567-4b4e-8dde-a3e1bfb9fd55 34 fields · synced May 30, 2026