Chemists’ Own Ear Wax Removal Drops

Organization name

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

SRN

PL-MF-000003485

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

Chemists’ Own Ear Wax Removal Drops

UDI-DI code

D-93502990069886G

Basic UDI-DI

B-93502990069886G

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

Chemists’ Own Ear Wax Removal Drops 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. This product contains docusate sodium, which helps to clear blocked ear canals by softening and breaking up ear wax. It also contains aloe vera extract, a natural ingredient known for its moisturising 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