OtoDual örondroppar

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.

• Do not use if package is damaged

  If the packaging has been damaged.

• 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.

  OTHER

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  An allergy to any of the components of the product has been previously detected; (Glycerol and lidokaine).

Primary placement in Poland; available across 4 countries total.

Trade name

OtoDual örondroppar

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05905718013395

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

5902020885058X

Reference / catalog number

N/A

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

AURIDOL örondroppar är en medicinteknisk produkt vars verkningsmekanism baseras på glycerolens osmotiska egenskaper. Huvudingrediensen i AURIDOL örondroppar är glycerol. Glycerol har två huvudsakliga egenskaper som är relevanta för dess användning i örondroppar: dess oljiga konsistens, som gör att den fäster skonsamt på huden vid appliceringsstället och ger skyddande egenskaper, samt dess hygroskopicitet, som gör att lokalt applicerad glycerol drar ut vatten ur svullna vävnader (osmotisk effekt). Detta minskar svullnaden och därmed även smärtans intensitet.

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)

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.