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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

SON1E — Class IIa MDR by PERSONUS Srl

MD Atlas
PERSONUS Srl

EUDAMED last updated this device on May 18, 2026

SON1E

805227545SON1ED8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PERSONUS Srl
UDI-DI code: 08052275452000
Reference / catalog number: SON1E

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View device family (Basic UDI)

Manufacturer information

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

Related devices

SON3CD80522754503P8On the market SON3CS80522754503P8On the market SON3ED80522754503P8On the market SON3ES80522754503P8On the market SON4CD80522754504PAOn 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.

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: 08052275452000
Basic UDI-DI: 805227545SON1ED8
Reference / catalog number: SON1E
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: • 8 Canali di definizione del segnale • 4 Bande di Guadagno • 4 Canali di compressione in Ingresso • Compressione in Uscita MULTICANALE • Fino a 4 programmi di ascolto • Gestione del Feedback • Gestione del rumore ambientale • Classificazione ambientale • Data Logging • Sportello pila con funzionalità on/off Caratteristiche • Interruttore dei programmi opzionale • Controllo di volume opzionale • Ritardo di accensione • Segnali di avviso adattivi, variabili in relazione all’ingresso • Segnale di pila scarica • Programmazione con HIPRO/NOAHLINK
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)08052275452000

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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.

Y2145060202HEARING AIDS IN-THE-CANAL (ITC)

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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