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Organization name
UDI-DI code
Reference / catalog number

Signal MR Head — Class I MDR by Floy GmbH

MD Atlas
Floy GmbH

Manufacturer information

Organization name: Floy GmbH
SRN: DE-MF-000016503
Manufacturer status: Active

EUDAMED last updated this device on May 8, 2026

Signal MR Head

426076104MRHEAD8Q

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Floy GmbH
UDI-DI code: 04260761040400
Reference / catalog number: Signal MR Head

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Manufacturer information

Organization name: Floy GmbH
SRN: DE-MF-000016503
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
See instructions for use

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 13, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260761040400
Basic UDI-DI: 426076104MRHEAD8Q
Reference / catalog number: Signal MR Head
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: See instructions for use
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Serial number
Software identification

Manufacturer information

Related devices

Signal MR Head

Manufacturer information

Critical warnings

Market distribution

Device identification

Classification

Device details

EMDN nomenclature code(s)

Compliance flags

Safety

Substances

Regulatory

Lifecycle

UDI-PI traceability

Related devices