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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

2140 — Class I MDD by Levante srl

MD Atlas
Levante srl

EUDAMED last updated this device on Jul 7, 2025

2140

B-AMICOBORSOL.ACQUOSALZ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Levante srl
UDI-DI code: D-AMICOBORSOL.ACQUOSALZ
Reference / catalog number: 2140

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Manufacturer information

Organization name: Levante srl
SRN: IT-MF-000036829
Manufacturer status: Active

Critical warnings

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

CW999
- Non ingerire. - Rimuovere eventuali apparecchi acustici prima di utilizzare AMICOBOR - Evitare il contatto con gli occhi. Nel caso di contatto accidentale lavare gli occhi con abbondante acqua. - Tenere fuori della portata dei bambini. - Pulire accuratamente l'erogatore dopo l'utilizzo. - Richiudere il flacone dopo l'uso. - Conservare a temperatura ambiente. Non esporre a fonti di calore. - Non disperdere il contenitore nell'ambiente. - Non utilizzare in caso di timpano perforato o di terapia farmacologica concomitante. - Non utilizzare il prodotto dopo la data di scadenza. - Se ne sconsiglia l 'uso in gravidanza. - Non utilizzare in caso di ipersensibilità nota ad uno dei componenti presenti nel prodotto. Qualora il prodotto dia luogo a fenomeni di sensibilizzazione, interrompere il trattamento e consultare ii medico. - Prima di utilizzare su bambini consultare il medico al fine di una corretta diagnosi. - Non utilizzare nel caso in cui il confezionamento non si presenti integro. - La data di scadenza si riferisce al prodotto in confezionamento integro, correttamente conservato.

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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: D-AMICOBORSOL.ACQUOSALZ
Basic UDI-DI: B-AMICOBORSOL.ACQUOSALZ
Reference / catalog number: 2140
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
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-AMICOBORSOL.ACQUOSALZ

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

EMDN nomenclature code(s)

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

Q03040299EAR IRRIGATION DEVICES - 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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Related devices

2128B-DIGETOP3SOn the market 2141B-AMICOBORSOL.ALCOLICA3BOn the market 21438053782190003ABC123OTK3On 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.