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Siemens Healthineers AG

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000038456 FEI 3002808157

Devices
37
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Siemens Healthineers AG makes

Siemens Healthineers AG manufactures medical imaging systems, including AI-assisted diagnostic tools like the AI-Rad Companion Chest CT and AI-Rad Companion Chest X-ray for automated analysis of radiographic scans. The company also produces physiological assessment devices, such as the myCoro Scout FFR for coronary pressure measurements, and advanced MRI and CT platforms like the BIOGRAPH One and syngo.MR Applications (VB80). Software solutions, including Syngo Carbon Clinicals (VA41), support clinical workflows and data management in radiology and cardiology settings.

The portfolio includes devices classified as Class II, Class IIa, and Class IIb under EU and FDA regulations, with entries listed in the EUDAMED database and FDA’s 510(k) clearance registry. The company is headquartered in Germany.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue37

Newest first, rows 1-37 of 37

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  • MAGNETOM Terra.X Ref 11371478

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Syngo Carbon Enterprise Access Ref 11926875

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Article 22 Comb. SENTICOR Ref 11735419

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MAGNETOM Cima.X Ref 11689616

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Cima.X Ref 11647158

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Cima.X Ref 11689304

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Flow.Elite Ref 11878345

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM CIma.X Fit Ref 11647159

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Flow.Neo Ref 11878344

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Flow.Neo Ref 11569835

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Flow.Elite Ref 11851911

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • BIOGRAPH One Ref 11689624

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Terra.X Ref 11371477

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Syngo Carbon Space Ref 11926807

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MAGNETOM Flow.Elite Ref 11851912

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Flow.Elite Ref K260852

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • LungMaps Ref K253690

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • MAGNETOM Flow.Neo Ref 11569839

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Syngo Carbon Space (VA4) Ref K263048

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • MAGNETOM Sola Ref 11410231

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • syngo Dynamics Ref 11708404

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • LungMaps Ref VA10A

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • SENTICOR Pure Ref 11735410

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • SOMATOM X.cite Combination AG Ref 11772701

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • MAGNETOM Free.XL Ref 11878375

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • MAGNETOM Free.XL Ref 11690226

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • BIOGRAPH One Ref 11689172

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • MAGNETOM Altea Ref 11410371

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • MAGNETOM Vida Ref 11516152

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • MAGNETOM Lumina Ref 11344916

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • SOMATOM X.ceed Combination AG Ref 11772702

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • AI-Rad Companion Chest CT Ref 11926838

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • myCoro Scout FFR Ref 11108440

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AI-Rad Companion Chest X-ray Ref 11926818

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • BIOGRAPH One Ref K253023

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • syngo.MR Applications (VB80) Ref K253495

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Syngo Carbon Clinicals (VA41) Ref K251059

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-37 of 37

Company details

EUDAMED SRN
DE-MF-000038456
SRN (system / procedure pack)
DE-PR-000038457
FDA FEI number
3002808157
DUNS number
314699460
EU VAT number
DE315879502
EUDAMED status
Active
EUDAMED registered name
Siemens Healthineers AG
Registered address
3, Siemensstr., 91301, Forchheim, Germany
Phone
+1(800)888-7436
PRRC contact
Joerg Teiche(public in EUDAMED)

From the company website

Read 18 Oct 2026

We pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Discover more about our innovative medtech and the people behind it.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Siemens Healthineers AG have in the registry?

The registry currently lists 37 devices for Siemens Healthineers AG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Siemens Healthineers AG's devices?

Among its 37 most recently registered devices, Siemens Healthineers AG has devices listed in EUDAMED (31 devices), FDA 510(k) (6 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Siemens Healthineers AG's devices fall under?

Among its 37 most recently registered devices, the classes recorded for Siemens Healthineers AG's devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Siemens Healthineers AG in the registry?

The most recently registered devices listed for Siemens Healthineers AG include MAGNETOM Terra.X, Syngo Carbon Enterprise Access, Article 22 Comb. SENTICOR and MAGNETOM Cima.X.

Generated automatically from registry data and not verified by a human reviewer.