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Organization name
UDI-DI code
Reference / catalog number

FOOTLYSER M NEO — Class I MDR by AMCUBE IST

MD Atlas
AMCUBE IST

EUDAMED last updated this device on Jul 3, 2024

FOOTLYSER M NEO

3770029424NEO79

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AMCUBE IST
UDI-DI code: 03770029424060
Reference / catalog number: FOOTLYSER M NEO

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Manufacturer information

Organization name: AMCUBE IST
SRN: FR-MF-000026132
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 24, 2024	Still on market

Device identification

Trade name: FOOTLYSER M NEO
UDI-DI code: 03770029424060
Basic UDI-DI: 3770029424NEO79
Reference / catalog number: FOOTLYSER M NEO
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: PLATEFORME DE BAROPODOMETRIE
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062603SENSOR-BASED PLATFORMS

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

Related devices

FOOTLYSER L NEO3770029424NEO79On the market FOOTLYSER S NEO3770029424NEO79On the market FOOTWORK NEO3770029424NEO79On the market FOOTWORKPRO NEO3770029424NEO79On the market

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.