MAGNETOM Sempra
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MAGNETOM Sempra EUDAMEDFDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMEDMDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMEDMRI Scanner FDA UDI
- Model / Reference
- 10840816 EUDAMEDFDA UDIMDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED11568942 EUDAMEDMDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMED
- Description
- MRI Scanner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869044538 EUDAMEDFDA UDI04056869265858 EUDAMED
- Basic UDI-DI
- 0405686900131UK EUDAMED0405686900126US EUDAMED
- FDA Product Code
- LNH FDA UDILNI FDA UDIMOS FDA UDI
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Spain EUDAMED
- Medical Purpose
- Combined use of the listed medical devices to enhance MRI diagnostic imaging in accordance with the respective instructions for use of the individual EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Full-body MRI system, superconducting magnet
MAGNETOM Sempra by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 Shenzhen Magnetic Resonance Ltd.
Sources (3)
- FDA UDI a047dd25-e450-4592-aa66-bdac7370ef92 34 fields · synced Oct 6, 2026
- EUDAMED 2c32f7a9-6b1b-4ad1-a86d-a7ae45e62809 61 fields · synced Jul 9, 2026
- EUDAMED 046d3de9-ebe0-47c9-9f20-50e21f396d39 61 fields · synced Jul 13, 2026