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Uroskop Omnia Max

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
Uroskop Omnia Max FDA UDI
Generic Name
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI
Device Name
Diagnostic Urology FDA UDI
Model / Reference
10762473 FDA UDI
Description
Diagnostic Urology FDA UDI

Identifiers

Primary DI / UDI-DI
04056869008981 FDA UDI
FDA Product Code
JAA FDA UDI
GMDN Term
Stationary uro-gynaecological fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary uro-gynaecological fluoroscopic x-ray system, digital

Uroskop Omnia Max by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary uro-gynaecological fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare

Sources (1)

  • FDA UDI 9986676a-5ff0-46b8-8e84-807af1749e88 34 fields · synced May 30, 2026