Dermosil Medi Burn treatment gel 100 ml

Organization name

Aurena Laboratories AB

SRN

SE-MF-000002890

Manufacturer status

Active

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

• 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

  Seek medical help if your condition lasts or gets worse or if your burn does not blanche with pressure.
• CW999

  If any serious incident occurs in relation to the device, report to the local competent authority and the manufacturer.
• CW999

  Do not use on deeper than superficial burns, i.e., do not use on non-blanching burns or other types of burns such as chemical burns, phototoxic reactions, drug induced skin reactions or skin damages induced by electric shock.

Primary placement in Sweden; available across 2 countries total.

Trade name

Dermosil Medi Burn treatment gel 100 ml

UDI-DI code

07332343300343

Basic UDI-DI

7332343200037H

Reference / catalog number

301422

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

Burn Gel

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.

• M04040501HYDROGEL DRESSINGS, NON-COMBINED