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NAEOTOM Alpha Combination
EUDAMEDClass IIb (EU MDR)
Ref 11501073Model CT-Scanner-COMBI_ERLN H 127
Identity
- Trade Name
- NAEOTOM Alpha Combination EUDAMED
- Device Name
- CT-Scanner-COMBI_ERLN H 127 EUDAMED
- Model / Reference
- CT-Scanner-COMBI_ERLN H 127 EUDAMED11501073 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869288345 EUDAMED
- Basic UDI-DI
- 0405686901999X4 EUDAMED
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Joint use of the listed medical devices to extend CT diagnostic imaging in accordance with the respective IFU of the individual devices EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
NAEOTOM Alpha Combination by Siemens Healthcare GmbH — 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 | 0405686901999X4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-PR-000020469
Sources (1)
- EUDAMED 2d235678-8969-46f3-994a-03f464e9564f 61 fields · synced Oct 7, 2026