31027

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 of the respiratory system. • The Product should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients. • If side effects occur, the use of the Product must be discontinued immediately. • After usage of one single dose unit, the remaining liquid must be discarded, it is not intended for later usage. • The Product is filled in small plastic parts that could be swallowed by small children. To avoid danger of suffocation, the Product should be kept out of reach of children. • Do not use damaged or punctured single dose units. • Do not inhale too quickly.

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

D-DE-MF-000006543-31027ST

Basic UDI-DI

B-DE-MF-000006543-31027ST

Reference / catalog number

31027

Issuing entity

EUDAMED

Risk category

Class IIa

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.

• R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS

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