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X-ray tube assembly 0.4/0.7JG326D-265
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 582-24838-02Model X-ray tube assembly J-seriesRef 582-24838-02
Identity
- Trade Name
- X-ray tube assembly 0.4/0.7JG326D-265 EUDAMED0.4/0.7JG326D-265 EUDAMEDFDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- X-ray tube assembly 0.4/0.7JG326D-265 EUDAMED
- Model / Reference
- X-ray tube assembly J-series EUDAMED582-24838-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217042098 EUDAMEDFDA UDI
- Basic UDI-DI
- 45402170200000000000002U5 EUDAMEDB-04540217042098 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
X-ray tube assembly 0.4/0.7JG326D-265 by Shimadzu Corporation — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 45402170200000000000002U5 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170200000000000002U5 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (3)
- EUDAMED 79e94264-7edb-4cc3-ab41-34df8c1c84f5 61 fields · synced Jul 9, 2026
- EUDAMED b8bea566-e944-4963-97c3-274c03aa9e97 61 fields · synced May 18, 2026
- FDA UDI b111df95-5696-4d72-bc25-8ec1e3d92b6f 32 fields · synced May 30, 2026