12000457

Organization name

Nirial Pharma srl

SRN

IT-MF-000018760

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW038

  EUDAMED did not publish a description for this code.
• CW054

  EUDAMED did not publish a description for this code.
• CW268

  EUDAMED did not publish a description for this code.
• CW277

  In case of undesirable reactions, stop treatment immediately, consult your doctor and inform the manufacturer.
• CW135

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

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

  External use: do not swallow or inhale. Avoid contact with the eyes, if contact occurs, rinse with plenty of water. Avoid exposing the treated area to the sunlight. Avoid direct contact between the spray container and the wound. In case of undesirable reactions, stop treatment immediately, consult your doctor and inform the manufacturer. Any serious incident occurring in relation to the device should be reported to the manufacturer and the competent authority of the Member State where the user and / or patient is established. There are no known interactions with medicines and medicinal products. Do not use in conjunction with other therapies or treatments in place that involve taking or topical use of other medical devices or drugs. Consult a doctor for prolonged use. Close the package after use. Do not use if the package is damaged or after its expiry date. Consult your doctor before using the product in pregnant and breastfeeding women. Do not use the product for more than 30 consecutive days. Contraindications: Do not use in case of known hypersensitivity or known allergy to one or more components.

Primary placement in Slovakia; available across 1 country total.

Trade name

not provided

UDI-DI code

08052990632404

Basic UDI-DI

805299063DERMA002UE

Reference / catalog number

12000457

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.

• M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER