38099

Organization name

bitop AG

SRN

DE-MF-000006543

Manufacturer status

Active

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

• CW999

  Children younger than 2 years should not use product.If allergic reactions occur, the use of product must be discontinued immediately.To ensure safe hygiene, each spray bottle should be used by one person only. Do not use for more than 3 months after opening.Product should be kept out of reach of children.Do not use if the device is damaged or punctured.If you have used a larger amount of product than you should, no adverse effects are to be expected if you have used 1-2 single doses too much once. If you have used significantly more and if you experience discomfort, please notify a doctor. Basically, the dosage recommendation should be followed. Additional information If recommended by your doctor or health care professional, product may be used after surgery and trauma.Safety of Salvia during pregnancy and while breast-feeding has not been established. In the absence of sufficient data, the use of product during pregnancy and while breast-feeding is not recommended.Children under 10 years and patients unable to use product on their own should be assisted during application of product. Should any serious incident related to product occur, please report it to the legal manufacturer of the product at vigilance@bitop.de and the responsible local competent authority.

Primary placement in Portugal; available across 1 country total.

Trade name

not provided

UDI-DI code

04260265220742

Basic UDI-DI

426026522BITOP-ERS-C168

Reference / catalog number

38099

Issuing entity

GS1

Risk category

Class IIb

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.

• Q0399ENT DEVICES - OTHER

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