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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

ML01-01 — Class I MDR by BionIT Labs S.r.l.

MD Atlas
BionIT Labs S.r.l.

EUDAMED last updated this device on Sep 26, 2025

ML01-01

805797159AHY5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BionIT Labs S.r.l.
UDI-DI code: 08057971595365
Reference / catalog number: ML01-01

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View device family (Basic UDI)

Manufacturer information

Organization name: BionIT Labs S.r.l.
SRN: IT-MF-000007793
Manufacturer status: Active

Related devices

AH02-RS3-N9-01805797159AHY5On the market AH02-LS3-N5-01805797159AHY5On the market AH02-LS3-N2-01805797159AHY5On the market AH02-RS3-B1-01-L805797159AHY5On the market AH02-LM3-B1-01-D805797159AHY5On 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.

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: 08057971595365
Basic UDI-DI: 805797159AHY5
Reference / catalog number: ML01-01
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: Software for configuring and customizing the Adam’s Hand device, designed for the orthopedic technician
Additional information URL: No additional information URL provided by the manufacturer.
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)08057971595365

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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.

Y061899UPPER EXTREMITY PROSTHESES - OTHER

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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