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RADspeed fit
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 566-12700-62Ref 566-12700-61Ref 566-12700-91Model Radiography System RADspeed fitRef 566-12700-60Ref 566-12700-71
Identity
- Trade Name
- RADspeed fit EUDAMED
- Device Name
- Radiography System RADspeed fit EUDAMED
- Model / Reference
- 566-12700-62 EUDAMED566-12700-61 EUDAMEDRadiography System RADspeed fit EUDAMED566-12700-91 EUDAMED566-12700-60 EUDAMED566-12700-71 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217062560 EUDAMED04540217062553 EUDAMED04540217069118 EUDAMED04540217062546 EUDAMED04540217062614 EUDAMED
- Basic UDI-DI
- B-04540217062560 EUDAMEDB-04540217062553 EUDAMEDB-04540217069118 EUDAMEDB-04540217062546 EUDAMEDB-04540217062614 EUDAMED
- EMDN Code
- Z11030506 TELERADIOGRAPHS 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
RADspeed fit by Shimadzu Corporation — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173517 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04540217062560 | 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 (6)
- EUDAMED bcbbd836-aad5-4a09-b947-e1c5cbcf5f5c 61 fields · synced Aug 3, 2026
- EUDAMED 5ed126aa-c99e-46a6-ba5e-3ffc7bf4cddb 61 fields · synced May 17, 2026
- EUDAMED d82bab70-295e-4ed6-90d5-b0735fbf34d8 61 fields · synced May 17, 2026
- EUDAMED b82d6c4d-10c7-42f0-a6bc-f0fe1560750e 61 fields · synced May 17, 2026
- EUDAMED 2e616bee-b839-4fa5-94e1-a14569d6b1c2 61 fields · synced May 18, 2026
- FDA 510(k) K173517 1 fields · synced May 18, 2026