38137

Organization name

bitop AG

SRN

DE-MF-000006543

Manufacturer status

Active

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

• CW999

  Donot use lozenges from damaged or punctured blisters. Product should not be used during persisting traumas, e.g. after surgery or injuries of the mouth. Do not use in children belowsixyearsdue to danger of suffocation. Do not use the lozenges while lying down, e.g. at bedtime, due to the risk of choking. 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 product must be discontinued immediately Product should be kept out of reach of children. Additional information Preservativeand sugar-free Lozengeswith Ectoin®, a natural, cell-protective molecule with inflammation-reducing and membrane-stabilizing properties. Theselozengesutilizethe cell-protectivemolecule Ectoin®. Itis a 100%naturalingredient obtained from microorganisms that live under extreme hostile environments (e.g. geysers, salt lakes, deserts). To protect themselves against the environmental stresses these micro-organisms produce Ectoin®. Lozenges have a pleasantwildberry and menthol flavour. 1 Lozenge (1g) contains 100 mg sorbitol and 422 mg maltitol (sugar substitutes). 1 Lozenge (1g) = 0.044BE

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

D-DE-MF-000006543-38137UL

Basic UDI-DI

B-DE-MF-000006543-38137UL

Reference / catalog number

38137

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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