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X-ray tube assembly 0.6/1J317C-282
EUDAMEDClass IIb (EU MDR)
Ref 582-24499-02Model X-ray tube assembly J-series
Identity
- Trade Name
- X-ray tube assembly 0.6/1J317C-282 EUDAMED0.6/1J317C-282 EUDAMED
- Device Name
- X-ray tube assembly 0.6/1J317C-282 EUDAMED
- Model / Reference
- X-ray tube assembly J-series EUDAMED582-24499-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217049271 EUDAMED
- Basic UDI-DI
- 45402170200000000000002U5 EUDAMEDB-04540217049271 EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
X-ray tube assembly 0.6/1J317C-282 by Shimadzu Corporation — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| 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 |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (2)
- EUDAMED 8d3a18e8-9ca0-44b0-ade4-b12c80a18778 61 fields · synced Jul 28, 2026
- EUDAMED bd2e24d3-20bf-43a1-80f4-6c7bde2719ad 61 fields · synced May 18, 2026