FTPR12

Organization name

Labomar S.p.A.

SRN

IT-MF-000007965

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW010

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

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

  EUDAMED did not publish a description for this code.
• CW135

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

  Before administering to children under three years of age, it is recommended that you seek the advice of your doctor. If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor, in any case do not use for more than 15 days. Do not take it if you are allergic, intolerant or hypersensitive to any component. Do not use for purposes other than that for which the product is intended. No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Authority. In case of any undesired event always seek medical advice. Expiry date refers to the product in its intact packaging, and properly stored. Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution due to lack of experimental data. Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding. In any case, consult your doctor before taking it. In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use. Do not exceed the recommended daily dose.

Primary placement in Netherlands; available across 2 countries total.

Trade name

not provided

UDI-DI code

08056300621805

Basic UDI-DI

805630062FTPR1297

Reference / catalog number

FTPR12

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

SPRAY GOLA FAMILY is a medical device composed of substances, non-sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of sore throat in adult and children (2+).

Additional information URL

https://labomar.com/en/products/ftpr-12-2/

Clinical sizes

No clinical sizes registered for this device.

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

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES