EUDAMED last updated this device on Mar 13, 2025

SONUS 5 ENDO (SINISTRO 114/57)

80522754505PC

On the marketClass IIa

Applicable legislation: —
Organization name: PERSONUS Srl
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 →: 08052275451225
Reference / catalog number: SON5ES

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.

SONUS 5 ENDO (SINISTRO 114/57) is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by PERSONUS Srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: SONUS 5 ENDO (SINISTRO 114/57)
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 →: 08052275451225
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 →: 80522754505PC
Reference / catalog number: SON5ES
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 →: GS1

Classification

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

Device details

Quantity: 1
Additional product description: • 10 Canali di definizione del segnale • 10 Canali di regolazione • Ottimizzazione del suono In-situ • Gestore del livello di esperienza • Fino a 3 programmi di ascolto Caratteristiche • Trasposizione lineare delle frequenze • Analisi acustica su 4 differenti situazioni • Riduzione del rumore impulsivo • Data Logging • Sportello pila con funzionalità on/off • Direzionalità adattiva automatica su 10 canali (ENDO / CIC) • Gestione del rumore ambientale • Algoritmo di riduzione del rumore • Registrazione delle preferenze • Controllo del volume • Zen • Ritardo di accensione • Segnali di avviso adattivi, variabili in relazione all’ingresso • Segnale di pila scarica • Programmazione WIRELESS • Programmazione con Cavi + Falsapila (CIC M)
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)08052275451225

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

Y2145060202HEARING AIDS IN-THE-CANAL (ITC)

Critical warnings

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

Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market

SONUS 5 ENDO (SINISTRO 114/57)

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI 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

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Certificates covering this device

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