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Siemens Wedge
EUDAMEDClass I (EU MDR)
Ref 56-300-DX15Model Siemens WedgeRef 56-300-MX30Ref 56-300-DI30Ref 56-300-MI60Ref 56-300-MI30Ref 56-300-MX45Ref 56-300-DI15Ref 56-300-DX45Ref 56-300-DX60Ref 56-300-MI15Ref 56-300-DI60
Identity
- Trade Name
- Siemens Wedge EUDAMED
- Device Name
- Siemens Wedge Filter DI15 EUDAMED
- Model / Reference
- Siemens Wedge EUDAMED56-300-DX15 EUDAMED56-300-MX30 EUDAMED56-300-DI30 EUDAMED56-300-MI60 EUDAMED56-300-MI30 EUDAMED56-300-MX45 EUDAMED56-300-DI15 EUDAMED56-300-DX45 EUDAMED56-300-DX60 EUDAMED56-300-MI15 EUDAMED56-300-DI60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B36556300DX150 EUDAMED+B36556300MX300 EUDAMED+B36556300DI300 EUDAMED+B36556300MI600 EUDAMED+B36556300MI300 EUDAMED+B36556300MX450 EUDAMED+B36556300DI150 EUDAMED+B36556300DX450 EUDAMED+B36556300DX600 EUDAMED+B36556300MI150 EUDAMED+B36556300DI600 EUDAMED
- Basic UDI-DI
- ++B36556300DI15EC EUDAMED
- Direct Marketing DI
- +B36556300DX150 EUDAMED+B36556300MX300 EUDAMED+B36556300DI300 EUDAMED+B36556300MI600 EUDAMED+B36556300MI300 EUDAMED+B36556300MX450 EUDAMED+B36556300DI150 EUDAMED+B36556300DX450 EUDAMED+B36556300DX600 EUDAMED+B36556300MI150 EUDAMED+B36556300DI600 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Siemens Wedge by Aktina Medical Corp — Class I — 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 | ++B36556300DI15EC | Class I | Active |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (11)
- EUDAMED 7f9754af-821f-4240-96da-cec5c8bbc37b 61 fields · synced Oct 6, 2026
- EUDAMED f4cadcae-837b-4065-9a7a-aa11aff075a6 61 fields · synced May 16, 2026
- EUDAMED 34a174e3-3e9f-4030-ac70-489d48447b75 61 fields · synced May 16, 2026
- EUDAMED 2a76262a-1e78-4b54-8244-e3f9cd103c3f 61 fields · synced May 16, 2026
- EUDAMED 9a79b59f-f7f5-44ff-9754-a417c493b4d9 61 fields · synced May 17, 2026
- EUDAMED 2610e361-ce23-43c7-a780-bdcdfd043fd8 61 fields · synced May 18, 2026
- EUDAMED 28c907ca-f6e7-4286-975a-56cf5a886b4f 61 fields · synced May 18, 2026
- EUDAMED 5cba724c-539e-40a8-ae25-ead8b5f14958 61 fields · synced May 18, 2026
- EUDAMED da62a369-f540-47ce-80fe-36fc70f61cd5 61 fields · synced May 18, 2026
- EUDAMED 8a686d2e-6199-43f9-88a9-5b3f07838137 61 fields · synced May 18, 2026
- EUDAMED 275364aa-5c1b-4a1d-a6e0-95bcd3848ccf 61 fields · synced May 19, 2026