-

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW999

  ONAK Herpes Labial is exclusively for external use, cutaneous application. Do not ingest the product. Do not apply ONAK Herpes Labial in case of hypersensitivity to any of its ingredients. Stop using the product if local hypersensitivity reactions appear in the application area. In case of any serious incident related to the product, notify the manufacturer and the competent health authority.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  Do not use after the date marked on the package
• CW275

  If you are pregnant or breastfeeding consult your doctor before using the product
• CW277

  If herpes or symptoms persist after 10 days, consult your doctor or pharmacist
• CW135

  For use in children under four years, consult a doctor or pharmacist. Keep out of the reach and sight of children.
• CW276

  Do not use with other products containing alcohol because alginate can precipitate in its presence

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08437027750373

Basic UDI-DI

8437015992UE0065G

Reference / catalog number

-

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU48

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

• M04040501HYDROGEL DRESSINGS, NON-COMBINED