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X22

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref X22 0.6/1.3

by I.a.e. Industria Applicazioni Elettroniche S.p.a.

Identity

Trade Name
X22 EUDAMEDFDA UDI
Generic Name
X-ray tube housing assembly, diagnostic FDA UDI
Device Name
X-ray tubes EUDAMED
Rotating anode X-ray tube for radiography systems FDA UDI
Model / Reference
X22 0.6/1.3 EUDAMED
0.6/1.3 FDA UDI
Description
Rotating anode X-ray tube for radiography systems FDA UDI

Identifiers

Primary DI / UDI-DI
08059307490023 EUDAMEDFDA UDI
Basic UDI-DI
805930749385G4 EUDAMED
Direct Marketing DI
08059307490023 EUDAMED
FDA Product Code
ITY FDA UDI
EMDN Code
Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
GMDN Term
X-ray tube housing assembly, diagnostic FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I FDA UDI
Regulation Number
892.1760 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

X22 by I.a.e. Industria Applicazioni Elettroniche S.p.a. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I.a.e. Industria Applicazioni Elettroniche S.p.a.
EUDAMED SRN
IT-MF-000021626

Sources (2)

  • EUDAMED b3a5cc79-91df-4adf-aeb0-d1f685fe8222 61 fields · synced Jun 18, 2026
  • FDA UDI 002e13b7-76df-49af-8468-a5e603e0402e 33 fields · synced May 30, 2026