← Back to catalogue
MAGNETOM Flow.Ace S
EUDAMEDClass IIa (EU MDR)
Ref 11571640Model MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom
Identity
- Trade Name
- MAGNETOM Flow.Ace S EUDAMED
- Device Name
- MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED
- Model / Reference
- MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom EUDAMED11571640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04068151017403 EUDAMED
- Basic UDI-DI
- 0405686900131UK EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIa 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
Clinical & Handling
Sterile
No
EUDAMED
Category: Full-body MRI system, superconducting magnet
MAGNETOM Flow.Ace S by Siemens Shenzhen Magnetic Resonance Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
- iTX Extremity 18 Flare Coil set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- MAGNETOM Sola Fit — Siemens Healthcare · Class II
- 8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
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 | 0405686900131UK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Shenzhen Magnetic Resonance Ltd.
- EUDAMED SRN
- CN-PR-000020467
Sources (1)
- EUDAMED db357be4-7462-4464-afc8-49632252f7f2 61 fields · synced Jun 18, 2026