SLBCRVN50

Organization name

Nirial Pharma srl

SRN

IT-MF-000018760

Manufacturer status

Active

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

• CW275

  Consult your doctor or pharmacist before using the product in pregnant, breastfeeding women and in children under 3 years old.
• CW010

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

  Do not use if the tube is open or damaged.
• CW135

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

  Any adverse event or serious accident occurring during use of the device must be promptly reported to the manufacturer identified on the product and in the instructions for use.
• CW999

  If any adverse reactions occur or an allergy to any of the ingredients emerges, the treatment should be discontinued.
• CW999

  Do not swallow. Avoid contact with your eyes; in case of contact, rinse immediately with plenty of water.
• CW999

  The use of the formulation can occasionally cause transient irritation. This is the only foreseeable side effects of the device, moreover it would be occasional and transient, without need of countermeasure.
• CW999

  Do not use in conjunction with other therapies or treatments in place that involve taking or topical use of other medical devices, drugs or supplements.
• CW999

  Any serious accident occurring in relation to the device must be promptly reported to the manufacturer and the competent authority of the Member State where the user and / or patient is established.
• CW999

  Do not rub the cream into the treated area after application. It is advisable to protect the medicated part with a sterile gauze.
• CW999

  Keep the package leaflet close at hand so that it can be consulted should the need arise.
• CW999

  Close the tube well after use.
• CW999

  Avoid direct contact between the tube and the lesion.
• CW999

  The product should be used by one person only so as to avoid the risk of cross contamination.

Primary placement in EL; available across 2 countries total.

Trade name

not provided

UDI-DI code

08052990630820

Basic UDI-DI

805299063DERMA001UC

Reference / catalog number

SLBCRVN50

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

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.

• M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)