301442

Organization name

Aurena Laboratories AB

SRN

SE-MF-000002890

Manufacturer status

Active

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

• CW999

  You have a history of perforation of the ear drum.
• CW999

  Your ears are inflamed.
• CW999

  There are any foreign bodies present in the ear canal.
• CW999

  You are currently being treated with a tympanic drain (grommets).
• CW268

  EUDAMED did not publish a description for this code.
• CW157

  EUDAMED did not publish a description for this code.
• CW139

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

  Do not expose to temperatures exceeding 50°C/122°F.
• CW999

  Protect from sunlight.
• CW999

  Keep out of reach of children.
• CW999

  The use of this device by more than one person may spread infections.
• CW999

  If symptoms persist (of ear wax) contact healthcare professionals.
• CW999

  If any serious incident occurs in relation to the device, report to the local competent authority and the manufacturer.

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

07332343300497

Basic UDI-DI

7332343200097V

Reference / catalog number

301442

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

REF 2013-3, Ear Spray, Isotonic, Seawater solution 100 ml

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.

• Q03040299EAR IRRIGATION DEVICES - OTHER