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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

01-BALBUS 5.0 — Class I MDR by Digitherapix S.R.L.

MD Atlas
Digitherapix S.R.L.

EUDAMED last updated this device on May 18, 2026

01-BALBUS 5.0

805875459BALB5.0JB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Digitherapix S.R.L.
UDI-DI code: 08058754590003
Reference / catalog number: 01-BALBUS 5.0

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View device family (Basic UDI)

Manufacturer information

Organization name: Digitherapix S.R.L.
SRN: IT-MF-000054427
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 4, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058754590003
Basic UDI-DI: 805875459BALB5.0JB
Reference / catalog number: 01-BALBUS 5.0
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: —
Additional information URL: https://digitherapix.com/download/istruzioni%20d'uso%20balbus%205.0.pdf
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)08058754590003

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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.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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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Related devices

02-COMMUNICATORAI805875459FT2COMAI029VOn 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.