APOHEALTH Ear Wax Drops

Organization name

Gofarm Sp. z o.o. Sp. k.

SRN

PL-MF-000003485

Manufacturer status

Active

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

• CW999

  Hypersensitivity (allergy) to product ingredients. Keep out of the reach and sight of children. Do not put ear dropper too deeply into ear canal to avoid its irritation or damage. Ear product. Avoid contact with eyes. Do not apply for nose. Do not swallow.
• CW010

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

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Poland; available across 1 country total.

Trade name

APOHEALTH Ear Wax Drops

UDI-DI code

D-93384750275769Y

Basic UDI-DI

B-93384750275769Y

Reference / catalog number

ENT46

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

Aurin Aloe is a preparation intended for removing residual wax from the ear and to prevent its recurrence. The preparation is used as an adjunct to clear the ear of secretions resulting from the otitis externa, in particular the auricle of fungal and bacterial etiology, manifested by itching of the ear, redness of the skin of the ear canal without or with slight edema. The medical device contains dioctyl sodium sulfosuccinate, which effectively removes ear wax, especially in children, aloe vera extract, responsible for maintaining proper hydration of the mucous membranes of the ear.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 12 MU03

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

• Q03040201EAR DROPPERS

Certificate health across this manufacturer's portfolio.