TFDM001

Organization name

Alfasigma S.p.A.

SRN

IT-MF-000017931

Manufacturer status

Active

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

• CW011

  Do not use in case of allergy / hypersensitivity to components of the formulation. Avoid using the product in the presence of known or suspected lesions of the external auditory meatus and / or tympanic membrane. Do not use in the presence of hearing aids. Product for external use. Avoid contact with eyes. Rinse eyes immediately if there is contact with the product. In the case in which you are using other products or drugs, wait for the time necessary before proceeding with the instillation of Debrox, to ensure the effectiveness of the treatment and to limit possible interactions. Do not swallow; if ingested quickly contact your doctor. Use of Debrox is not known to affect your ability to drive or operate machinery. However, the accumulation of earwax can cause dizziness and/or hearing loss, and these conditions may be temporarily exacerbated by the drops. If such effects occur, wait for their end before making any hazardous activity (e.g. using machines) or drive. Debrox can be used during pregnancy and lactation. The ingredients are widely used in similar devices for many years, without any negative reports. However, clinical studies have not been conducted in this regard. Do not share the bottle with other people, in order to prevent the transmission of possible infections that may be present. Consult your doctor if: • occur persistent heartburn; • symptoms are still present at the end of treatment; • there is a worsening of symptoms caused by stage of ear wax (eg irritation, pain, hearing loss, dizziness and tinnitus).
• CW135

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

D-0200031134

Basic UDI-DI

B-0200031134

Reference / catalog number

TFDM001

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 15 MU03

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

D-0200031134

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

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

• Q030499OTOLOGY DEVICES - OTHER