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0.6/1j317c-282
EUDAMEDClass IIb (EU MDR)
Ref 582-24499-01Model X-ray tube assembly 0.6/1J317C-282Model X-ray tube assembly J-series
Identity
- Trade Name
- 0.6/1J317C-282 EUDAMEDX-ray tube assembly 0.6/1J317C-282 EUDAMED
- Model / Reference
- X-ray tube assembly 0.6/1J317C-282 EUDAMED582-24499-01 EUDAMEDX-ray tube assembly J-series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217047215 EUDAMED
- Basic UDI-DI
- B-04540217047215 EUDAMED45402170200000000000002U5 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
0.6/1j317c-282 by Shimadzu Corporation — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04540217047215 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217047215 | 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 d189e6be-2fab-4b2e-9ac4-e2fde6be81dd 61 fields · synced Jun 19, 2026
- EUDAMED 80bf47d2-d496-4474-866b-1c748e52939c 61 fields · synced May 17, 2026