Earclin 3 in 1

Organization name

PK Benelux BV

SRN

NL-MF-000006672

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  The ear spray must not be used in the case of inflammation of the ear or earache, foreign objects in the ear, perforation of the eardrum or by anyone with eardrum tubes. Stop using the ear spray if ringing in the ears (tinnitus) or dizziness occurs or if pain is repeatedly experienced immediately after the ear spray is applied. Consult your doctor in case of doubt. Ear spray must not be used by anyone who is hypersensitive to (has an allergy) one or more of the ingredients. Skin reddening, itchiness, persistent weeping or earache immediately after spraying may be an indication of hypersensitivity. The spray contains soap and may cause irritation if used in the mouth or eyes. If the spray should be accidently sprayed in the mouth or eye, immediately rinse the affected area using plenty of water. The use during pregnancy or lactation is only recommended after consultation with your doctor.

Primary placement in Poland; available across 1 country total.

Trade name

Earclin 3 in 1

UDI-DI code

D-073453P2

Basic UDI-DI

B-073453P2

Reference / catalog number

073453

Issuing entity

EUDAMED

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

To remove cerumen congestion in adults and children older than 3 years

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

D-073453P2

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Q03040299EAR IRRIGATION DEVICES - OTHER