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0.7/1.2jg326d-265
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 582-24825-51Ref 582-24825-42
Identity
- Trade Name
- 0.7/1.2JG326D-265 EUDAMED0.7/1.2JG326 D-265 FDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Device Name
- X-ray tube assembly 0.7/1.2JG326D-265 EUDAMED
- Model / Reference
- 582-24825-51 EUDAMED582-24825-42 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217047390 EUDAMED04540217060788 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217047390 EUDAMEDB-04540217060788 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
0.7/1.2jg326d-265 by Shimadzu Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217047390 | 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 ade2b280-7a1b-442d-9be8-04cef57c008a 61 fields · synced Jul 28, 2026
- EUDAMED c578bbc6-fe41-4c69-90bf-ffb9276a8e3d 61 fields · synced May 19, 2026
- FDA UDI 61fb6b2a-6f20-40a2-bb9d-d277cb54af2c 32 fields · synced May 30, 2026