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System SOMATOM Drive
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10431700Model CT-Scanner_IIb_ERLN H 127
Identity
- Trade Name
- SOMATOM Drive EUDAMEDSystem SOMATOM Drive FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- CT-Scanner_IIb_ERLN H 127 EUDAMED
- Model / Reference
- 10431700 EUDAMEDFDA UDICT-Scanner_IIb_ERLN H 127 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869006970 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900117UR EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Germany 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
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
Prescription Use
Yes
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
No
FDA UDI
Category: Full-body CT system
System SOMATOM Drive by Siemens Healthcare — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K190578 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (2)
- FDA UDI 35a81893-e0cf-462a-9393-64c5afb77990 35 fields · synced Aug 4, 2026
- EUDAMED 06ee04bd-d2c9-41e1-8749-47301f5cf8d3 61 fields · synced Aug 4, 2026