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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

LEO M1 — Class I MDR by BIEMME GROUP SRL

MD Atlas
BIEMME GROUP SRL

EUDAMED last updated this device on Oct 10, 2025

LEO M1

805050779004AK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIEMME GROUP SRL
UDI-DI code: 08050507793013
Reference / catalog number: LEO M1

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View device family (Basic UDI)

Manufacturer information

Organization name: BIEMME GROUP SRL
SRN: IT-MF-000031381
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08050507793013
Basic UDI-DI: 805050779004AK
Reference / catalog number: LEO M1
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: Unique and innovative device dedicated to children with walking disorders. LEO provides hands free movement. LEO brings numerous physical, cognitive and relational benefits to the user. LEO helps therapists by giving the possibility to position a child into the device in sitting position
Additional information URL: https://www.biemmegroupsrl.it/
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

Encoded

(01)08050507793013

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y050201STANDING SUPPORT GAIT TRAINERS

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

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