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HeliCool V CXB-500B
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref -Model X-ray Tube Assembly
Identity
- Trade Name
- HeliCool V CXB-500B EUDAMEDRotating Anode X-ray Tube Assembly FDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- Diagnostic X-ray Tube Housing Assembly FDA UDI
- Model / Reference
- X-ray Tube Assembly EUDAMED- EUDAMEDCXB-500B FDA UDI
- Description
- Diagnostic X-ray Tube Housing Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580274412205 EUDAMEDFDA UDI
- Basic UDI-DI
- 45802744133523659295537M9 EUDAMED
- FDA Product Code
- ITY FDA UDI
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY 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
- Germany 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HeliCool V CXB-500B by Canon Electron Tubes & Devices Co., Ltd. — 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 | 45802744133523659295537M9 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Canon Electron Tubes & Devices Co., Ltd.
- EUDAMED SRN
- JP-MF-000009481
- Authorised Representative
- Canon Medical Components Europe B.V. NL-AR-000029305
Sources (2)
- EUDAMED db3bc82b-81e9-44cc-8921-fe71754dc29a 61 fields · synced Jul 9, 2026
- FDA UDI b90660e1-b019-41d9-8ad4-0340d48a4848 33 fields · synced May 29, 2026