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Mobile X-ray System Mobirex i9
EUDAMEDClass IIb (EU MDR)
Ref 566-20000-76Model Mobile X-ray System Mobirex i9Ref 566-20000-78
Identity
- Trade Name
- Mobile X-ray System Mobirex i9 EUDAMED
- Model / Reference
- Mobile X-ray System Mobirex i9 EUDAMED566-20000-76 EUDAMED566-20000-78 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217072729 EUDAMED04540217072743 EUDAMED
- Basic UDI-DI
- 45402170100000000000014SV EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER 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
Mobile X-ray System Mobirex i9 by Shimadzu Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 45402170100000000000014SV | 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 6be87e75-e000-4b4e-b554-2681f52d609c 61 fields · synced Sep 17, 2026
- EUDAMED 976ecb31-86be-4fba-a60a-59a8672d8a89 61 fields · synced May 18, 2026