33041

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 during persisting traumas, for example after surgery or injuries of the mouth. • The Product should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the lozenges. • If allergic reactions occur, the use of the Product must be discontinued immediately. • Children younger than 6 years should not use the Product due to danger of suffocation. • Do not use the lozenges while lying down, for example at bedtime, due to the risk of choking. • Do not use lozenges from damaged or punctured blisters. • The Product should be kept out of reach of children. Additional information Currently, there are no data available regarding the use of the Product during pregnancy and while breast-feeding. Consult your healthcare provider or pharmacist for advice before using this medical device if you are • pregnant or breast-feeding • not sure whether you are pregnant or not.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

D-DE-MF-000006543-33041T3

Basic UDI-DI

B-DE-MF-000006543-33041T3

Reference / catalog number

33041

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

• Batch number
• Expiration date
• Manufacturing date
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• Software identification