Identity
- Trade Name
- Mobirex i9 EUDAMEDFDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Mobile X-ray System Mobirex i9 EUDAMED
- Model / Reference
- 566-20000-26 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217064991 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04540217064991 EUDAMED
- FDA Product Code
- IZL FDA UDI
- EMDN Code
- Z11030506 TELERADIOGRAPHS EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mobirex i9 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-04540217064991 | 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
- Canon Medical Systems Europe B.V. NL-AR-000010531
Sources (2)
- EUDAMED 2701087f-4647-4a3b-ab10-6f79dd9a84d6 61 fields · synced Jun 18, 2026
- FDA UDI 6d6d471c-a887-4052-a5af-4c11aee7eabe 32 fields · synced May 30, 2026