31000

Organization name

bitop AG

SRN

DE-MF-000006543

Manufacturer status

Active

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

• CW999

  Warnings and precautions • The Product should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the nasal spray. • If allergic reactions occur, the use of the Product must be discontinued immediately. • Do not use if the device is damaged or punctured. • To ensure safe hygiene, each nasal spray bottle should only be used by one person. • Do not use for more than 3 months after opening. • The Product should be kept out of reach of children. If the Product is applied within its intended use, there is no evidence for a particular risk during pregnancy or breast-feeding. The Product is suitable for children. Children 10 years of age and younger and patients unable to use the Product on their own should be assisted during the application of the Product.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

D-DE-MF-000006543-31000S7

Basic UDI-DI

B-DE-MF-000006543-31000S7

Reference / catalog number

31000

Issuing entity

EUDAMED

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC 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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• Expiration date
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• Software identification