N/A

Organization name

EmergoPharm Spółka z ograniczoną odpowiedzialnością Sp. K.

SRN

PL-MF-000007178

Manufacturer status

Active

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

• CW007

  Do not use: if the packaging has been damaged;
• CW999

  • if the ear drum is damaged (e.g. chronic otitis media); • medical device should only be used after a thorough otoscopic examination by a doctor; • the expiry date printed on the packaging has expired; • the patient is immediately after surgery or surgical treatment in the ear; • in children under 6 months of age; • in case of prolonged pain or swelling caused by inflammatory condition with bacterial or fungal basis, these ailments require contact with a doctor; • in case of ear discharge - leakage from the ear; • medical device should not be applied to the ear with the hearing aid fitted, medical device should be applied one hour before the hearing aid is ingested into the outer ear canal; • although there is no evidence that medical device drops have a negative effect when used during pregnancy and breast-feeding, the use of medical device drops should be consulted with a doctor who should assess whether the expected benefits of it exceed the potential risk; • if symptoms intensify or there is no improvement after three days of using medical device ear drops or if you have a fever, contact your doctor. Prolonged pain or swelling may signal a bacterial or fungal infection that may require further and more appropriate treatment; • for external use only; • avoid contact with eyes, mouth and throat and nose mucous membranes; • It is intended for temporary relief of ear pain, no longer than 3 days and should not be used chronically.
• CW129

  An allergy to any of the components of the product has been previously detected; (glycerol and lidocaine)

Primary placement in Poland; available across 2 countries total.

Trade name

not provided

UDI-DI code

05905718013326

Basic UDI-DI

B-05905718013326

Reference / catalog number

N/A

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Easyear ear drops is a medical device, the action of which is based on the osmotic properties of glycerol. The main component of Easyear is glycerol. Glycerol has two basic characteristics relevant to its use in ear drops: 1) the oily consistency of glycerol, which causes it to adhere gently to the skin at the application site and is responsible for its protective properties and 2) hygroscopicity of glycerol, which in turn causes glycerol administered topically to remove water from swollen tissues (osmotic effect), resulting in swelling reduction, and thus the alleviation of pain.

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

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

• M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)