EUDAMED last updated this device on Apr 22, 2026

ESOXX ONE

B-ITMF00002471000029F

On the marketClass III

Applicable legislation: —
Organization name: Biofarma S.r.l.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-ITMF00002471000029F
Reference / catalog number: NA

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ESOXX ONE is an EU-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Biofarma S.r.l.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ESOXX ONE
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-ITMF00002471000029F
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-ITMF00002471000029F
Reference / catalog number: NA
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED

Classification

Risk category: Class III
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
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

D-ITMF00002471000029F

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

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

G0401ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Nessuna controindicazione in particolare, salvo casi di ipersensibilità nei confronti di uno dei suoi componenti. In tale circostanza interrompere il trattamento e contattare il proprio medico. Anche se non sono conosciuti effetti collaterali, si consiglia di non utilizzare il prodotto durante la gravidanza o nei primi mesi dell’allattamento. In ogni caso, consultare prima il proprio medico. Non eccedere la dose consigliata. Se le manifestazioni dovessero persistere consultare il proprio medico. Non essendo disponibili dati clinici sui bambini al di sotto dei 12 anni, non somministrare il prodotto a bambini al di sotto dei 12 anni.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 8 countries total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
France	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Slovakia	—	Still on market

Related searches

Class III medical devices in EUDAMED

Device identification

Trade name: ESOXX ONE
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-ITMF00002471000029F
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-ITMF00002471000029F
Reference / catalog number: NA
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Nessuna controindicazione in particolare, salvo casi di ipersensibilità nei confronti di uno dei suoi componenti. In tale circostanza interrompere il trattamento e contattare il proprio medico. Anche se non sono conosciuti effetti collaterali, si consiglia di non utilizzare il prodotto durante la gravidanza o nei primi mesi dell’allattamento. In ogni caso, consultare prima il proprio medico. Non eccedere la dose consigliata. Se le manifestazioni dovessero persistere consultare il proprio medico. Non essendo disponibili dati clinici sui bambini al di sotto dei 12 anni, non somministrare il prodotto a bambini al di sotto dei 12 anni.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 8 countries total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
France	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Slovakia	—	Still on market

ESOXX ONE

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Legacy certificates

Related devices

Certificates