04720-04703

Organization name

MONTEFARMACO OTC SPA

SRN

IT-MF-000013309

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW262

  L’amplificatore acustico deve essere utilizzato solo dalla persona a cui è destinato e non da altri.
• CW010

  EUDAMED did not publish a description for this code.
• CW024

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW011

  Non usare gli amplificatori acustici in aree con rischio di atmosfere esplosive o arricchite di ossigeno. Verificate la presenza di reti wireless o apparecchiature elettroniche nelle vicinanze che potrebbero creare disturbi al buon funzionamento del dispositivo.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

D-MINIP2

Basic UDI-DI

B-MINIP2

Reference / catalog number

04720-04703

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

ITC (In The Canal) Amplifier device assembled with an electronic main unit to be placed inside the ear canal, with the inner extremity into the ear canal covered by a silicone rubber tip for a safe and correct fitting.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-MINIP2

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

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

• Y214599HEARING AIDS - OTHER