EUDAMED last updated this device on Jul 16, 2026

FLUOCART

++B475FK9Y

On the marketClass I

Applicable legislation: —
Organization name: FLUOPTICS SAS
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B475FKCL0
Reference / catalog number: FK-CL

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

FLUOCART is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by FLUOPTICS SAS. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: FLUOCART
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B475FKCL0
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: ++B475FK9Y
Reference / catalog number: FK-CL
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eifu.getinge.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+B475FKCL0

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z119080VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 21 countries total.

Country	On market since	Until
GermanyPrimary placement	Jul 28, 2015	Still on market
Austria	Dec 20, 2019	Still on market
Belgium	Mar 15, 2017	Still on market
Cyprus	Jun 22, 2021	Still on market
Czechia	Mar 22, 2022	Still on market
Denmark	Oct 12, 2017	Still on market
EL	Jun 27, 2019	Still on market
Spain	May 20, 2016	Still on market
Finland	Dec 13, 2018	Still on market
France	Jul 22, 2015	Still on market
Hungary	Feb 24, 2026	Still on market
Iceland	Jun 29, 2023	Still on market
Italy	Feb 14, 2018	Still on market
Netherlands	Mar 17, 2020	Still on market
Norway	Mar 9, 2021	Still on market
Poland	Dec 19, 2019	Still on market
Romania	Mar 5, 2020	Still on market
Sweden	Mar 10, 2021	Still on market
Slovenia	Feb 28, 2025	Still on market
Slovakia	Nov 21, 2025	Still on market
Türkiye	Dec 19, 2024	Still on market

Related searches

Class I medical devices in EUDAMED

Device identification

Trade name: FLUOCART
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: +B475FKCL0
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: ++B475FK9Y
Reference / catalog number: FK-CL
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: HIBCC

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 21 countries total.

Country	On market since	Until
GermanyPrimary placement	Jul 28, 2015	Still on market
Austria	Dec 20, 2019	Still on market
Belgium	Mar 15, 2017	Still on market
Cyprus	Jun 22, 2021	Still on market
Czechia	Mar 22, 2022	Still on market
Denmark	Oct 12, 2017	Still on market
EL	Jun 27, 2019	Still on market
Spain	May 20, 2016	Still on market
Finland	Dec 13, 2018	Still on market
France	Jul 22, 2015	Still on market
Hungary	Feb 24, 2026	Still on market
Iceland	Jun 29, 2023	Still on market
Italy	Feb 14, 2018	Still on market
Netherlands	Mar 17, 2020	Still on market
Norway	Mar 9, 2021	Still on market
Poland	Dec 19, 2019	Still on market
Romania	Mar 5, 2020	Still on market
Sweden	Mar 10, 2021	Still on market
Slovenia	Feb 28, 2025	Still on market
Slovakia	Nov 21, 2025	Still on market
Türkiye	Dec 19, 2024	Still on market

FLUOCART

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Market distribution

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Manufacturer information

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Certificates

Certificates covering this device