04700-04701

Organization name

MONTEFARMACO OTC SPA

SRN

IT-MF-000013309

Manufacturer status

Active

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

• CW024

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

  EUDAMED did not publish a description for this code.
• CW262

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.
• CW143

  Non usare gli amplificatori acustici in aree con rischio di atmosfere esplosive o arricchite di ossigeno.
• CW011

  Verificate la presenza di reti wireless o apparecchiature elettroniche nelle vicinanze che potrebbero creare disturbi al buon funzionamento del dispositivo. L’amplificatore acustico deve essere utilizzato solamente dall’utente per cui l’uso è previsto. L’utilizzo da parte di altri soggetti non è consentito perché l’amplificatore acustico potrebbe provocare danni all’udito.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

D-AAPLATINUMJZ

Basic UDI-DI

B-AAPLATINUMJZ

Reference / catalog number

04700-04701

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

RIC (Receiver In Canal) Amplifier device assembled with an electronic main unit to be placed over the concha of the ear, connected by wire to loudspeaker (Receiver unit) to be placed inside the ear canal and covered by a silicone rubber tip for a safe and correct fitting inside the ear.

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-AAPLATINUMJZ

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