Identity
- Trade Name
- 0.3/0.8P324DK-85 EUDAMED0.8P324DK-85 EUDAMED
- Device Name
- X-ray tube assembly 0.3/0.8P324DK-85 EUDAMEDX-ray tube assembly 0.8P324DK-85 EUDAMED
- Model / Reference
- 582-24484-50 EUDAMED582-24485-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217062232 EUDAMED04540217062249 EUDAMED
- Basic UDI-DI
- B-04540217062232 EUDAMEDB-04540217062249 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
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
0.3/0.8p324dk-85 by Shimadzu Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217062232 | 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 72f49757-5552-45c7-b9c6-857573178436 61 fields · synced Jul 16, 2026
- EUDAMED 1d403953-a0f5-4cad-9027-f4162be14f54 61 fields · synced May 19, 2026