Identity
- Trade Name
- C52 EUDAMEDFDA UDI
- Generic Name
- X-ray system tube rotating anode assembly FDA UDI
- Device Name
- X-ray tube assemblies EUDAMEDRotating anode X-ray tube unit for radiography systems FDA UDI
- Model / Reference
- C52 EUDAMEDFDA UDI
- Description
- Rotating anode X-ray tube unit for radiography systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059307491464 EUDAMEDFDA UDI
- Basic UDI-DI
- 805930749384G2 EUDAMED
- Direct Marketing DI
- 08059307491464 EUDAMED
- FDA Product Code
- ITY FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- X-ray system tube rotating anode assembly 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
C52 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 | 805930749384G2 | 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 c2e2276e-e3cb-40bd-867e-b2cb6e1c9334 61 fields · synced Jul 9, 2026
- FDA UDI d9881542-1614-4365-8cd1-bf07224ac53a 33 fields · synced May 30, 2026