Identity
- Trade Name
- X42 EUDAMEDFDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- X-ray tubes EUDAMEDRotating anode X-ray tube for radiography systems FDA UDI
- Model / Reference
- X42 0.6/1.5 EUDAMED0.6/1.5 FDA UDI
- Description
- Rotating anode X-ray tube for radiography systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059307490177 EUDAMEDFDA UDI
- Basic UDI-DI
- 805930749385G4 EUDAMED
- Direct Marketing DI
- 08059307490177 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 EUDAMEDClass 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
X42 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805930749385G4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- I.a.e. Industria Applicazioni Elettroniche S.p.a.
- EUDAMED SRN
- IT-MF-000021626
Sources (2)
- EUDAMED c2a80064-422f-41bf-8b2f-5456668a74a0 61 fields · synced Jul 21, 2026
- FDA UDI 1fd7ef45-300f-45b4-af6f-8e3ae341b0c5 33 fields · synced May 29, 2026