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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

FBLXR — Class IIa MDR by FLUOPTICS SAS

MD Atlas
FLUOPTICS SAS

EUDAMED last updated this device on Apr 3, 2026

FBLXR

++B475FBLXR36

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FLUOPTICS SAS
UDI-DI code: +B475FBLXR0
Reference / catalog number: FBLXR

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Manufacturer information

Organization name: FLUOPTICS SAS
SRN: FR-MF-000000403
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Feb 21, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: +B475FBLXR0
Basic UDI-DI: ++B475FBLXR36
Reference / catalog number: FBLXR
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
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.

EMDN nomenclature code(s)

Z119080VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

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
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.