Pharmacy Choice Ear Wax Removal 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.

• 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.
• CW999

  Do not use this product if you have perforation of the ear drum (tympanic membrane), ear drainage, ear infection, earache or the ear cannot drain the wax properly. If you have any of the above conditions, consult your pharmacist or doctor before using this product. In case of infection, earache or other disturbing symptoms, the medical device should be used only after consultation with a physician. Do not place the dropper too deeply into the ear canal, as this may cause irritation or damage. Do not swallow the contents of this product. Do not instil this product into the eyes or nose.

Primary placement in Poland; available across 1 country total.

Trade name

Pharmacy Choice Ear Wax Removal Drops

UDI-DI code

D-9316100306296V7

Basic UDI-DI

B-9316100306296V7

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

Pharmacy Choice® Wax Removal Ear Drops are a mild preparation intended for ear hygiene and to remove accumulated wax from the ear. 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. This product contains dioctyl sodium sulfosuccinate, which removes ear wax; and aloe vera extract, a natural ingredient known for its soothing properties.

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.