MAGNETOM Flow.Plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MAGNETOM Flow.Plus EUDAMEDFDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMEDMDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED
- Model / Reference
- 11571312 EUDAMEDFDA UDI11571313 EUDAMEDFDA UDIMDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom EUDAMEDMDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED11571090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869997926 EUDAMEDFDA UDI04056869997933 EUDAMEDFDA UDI04056869999661 EUDAMED
- Basic UDI-DI
- 0405686900126US EUDAMED0405686900131UK EUDAMED
- 510(k) Number
- K250436 FDA UDI
- FDA Product Code
- LNI FDA UDILNH 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
- Germany EUDAMEDBulgaria 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 Flow.Plus by Siemens Shenzhen Magnetic Resonance Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
- MAGNETOM Sola Fit — Siemens Healthcare · Class II
- Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
- Head/Neck 20 MR Coil 1.5T — Siemens Healthcare · Class II
- Head 32 MR Coil Set 3T 098 — Siemens Healthcare · Class II
- Flex large 4 MR coil set 3T — Siemens Healthcare · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
Sources (5)
- FDA UDI 3e5d3b26-6475-46e8-a0f4-679f8b7d1bf4 34 fields · synced Jul 24, 2026
- FDA UDI b0d8993c-6087-446a-84d1-1b7a73ae1613 34 fields · synced May 30, 2026
- EUDAMED e5ee6d77-521a-4bec-8fd7-846d99767515 61 fields · synced Jul 14, 2026
- EUDAMED 7149b815-93b4-432c-949e-f4e22a9cf5d3 61 fields · synced Jul 21, 2026
- EUDAMED 0d1a028e-aab4-48a7-8915-a5534c53f5d3 61 fields · synced Jul 24, 2026