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Biograph mCT 20 Excel combination
EUDAMEDClass IIb (EU MDR)
Ref 11521491Model MDR_SPPP_11_IIb_HES_Comb.PET-CT
Identity
- Trade Name
- Biograph mCT 20 Excel combination EUDAMED
- Device Name
- MDR_SPPP_11_IIb_HES_Comb.PET-CT EUDAMED
- Model / Reference
- MDR_SPPP_11_IIb_HES_Comb.PET-CT EUDAMED11521491 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869979830 EUDAMED
- Basic UDI-DI
- 0405686902226VD EUDAMED
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- PET/CT Diagnostic Imaging System EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Biograph mCT 20 Excel combination by Siemens Medical Solutions Usa, Inc. — 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 | 0405686902226VD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- EUDAMED SRN
- US-PR-000020471
Sources (1)
- EUDAMED d78c0de5-4b6e-49b9-80f3-caefdfd2c0c8 61 fields · synced Jun 19, 2026