Identity
- Trade Name
- X22 HS 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
- X22 HS 0.8 EUDAMED0.8 FDA UDI
- Description
- Rotating anode X-ray tube for radiography systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059307490061 EUDAMEDFDA UDI
- Basic UDI-DI
- 805930749385G4 EUDAMED
- Direct Marketing DI
- 08059307490061 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
X22 Hs by I.a.e. Industria Applicazioni Elettroniche S.p.a. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 a382db6d-3c8a-4b76-be0a-0574264c57ec 61 fields · synced Jul 19, 2026
- FDA UDI efae8059-18c3-4282-b42f-9a94cea16d19 33 fields · synced May 30, 2026