38074

Trade name

not provided

UDI-DI code

04260265220254

Basic UDI-DI

426026522SNS013K9Y

Reference / catalog number

38074

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.

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

• Q0399ENT DEVICES - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Warnings and Precautions If allergic reactions occur, the use of the Product must be discontinued immediately.Do not use the device if it is damaged or punctured.To ensure safe hygiene, each nasal spray bottle is to be used by one person only.Do not use for more than 3 months after opening.Do not use after expiry date.Keep out of reach of children.If conditions persist or worsen, contact your healthcare provider.If you have applied a higher amount of the Product than you should, no negative effects are expected. If you are experiencing discomfort, please contact a doctor. Additional information If the Product is used within its intended use, there is no evidence for a particular risk during pregnancy and breast-feeding.Should any serious incident related to the Product occur, please report it to the legal manufacturer of the product at vigilance@bitop.de and the responsible local competent authority

No certificate specifically references this device's Basic UDI-DI.