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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

STDSON5 — Class IIa MDR by PERSONUS Srl

MD Atlas
PERSONUS Srl

EUDAMED last updated this device on May 25, 2026

STDSON5

805227545STDSON5VF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PERSONUS Srl
UDI-DI code: 08052275452147
Reference / catalog number: STDSON5

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View device family (Basic UDI)

Manufacturer information

Organization name: PERSONUS Srl
SRN: IT-MF-000032051
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08052275452147
Basic UDI-DI: 805227545STDSON5VF
Reference / catalog number: STDSON5
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
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)08052275452147

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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.

Y2145060203HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC)

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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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.