Remo-Wax Spray

Organization name

Orion Oyj

SRN

FI-MF-000001595

Manufacturer status

Active

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

• CW135

  EUDAMED did not publish a description for this code.
• CW999

  Do not use Remo Wax if the ear is inflamed or sore, the ear is secreting, the eardrum is injured, perforated or has been punctured (e.g. an ear tube). Do not use Remo-Wax if you are allergic (hypersensitive) to any of the ingredients of Remo-Wax.

Primary placement in Poland; available across 4 countries total.

Trade name

Remo-Wax Spray

UDI-DI code

06432100050786

Basic UDI-DI

643210REM001UD

Reference / catalog number

154712

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Remo-Wax solution is a yellowish, clear or opalescent liquid intended to be used as ear drops or ear spray and it is applied in the ear in order to dissolve impacted ear wax. After using Remo-Wax, the ear canal must be irrigated with water by using ear pump (bulb syringe) or user may visit a health care professional for ear irrigation

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Q030499OTOLOGY DEVICES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.