04704

Organization name

MONTEFARMACO OTC SPA

SRN

IT-MF-000013309

Manufacturer status

Active

6 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.
• CW023

  EUDAMED did not publish a description for this code.
• 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

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

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

D-COMFORT7Q

Basic UDI-DI

B-COMFORT7Q

Reference / catalog number

04704

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

BTE (Behind The Ear) Amplifier device assembled with an electronic main unit to be placed behind the concha of the ear, a thin tube which delivers the amplified sound into 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-COMFORT7Q

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