Granions® Mal de Gorge Intense

Organization name

bitop AG

SRN

DE-MF-000006543

Manufacturer status

Active

11 warnings recorded — scroll inside the panel to see all entries.

• CW275

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW277

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW999

  Children younger than 6 years should not use the device due to danger of suffocation.
• CW999

  Do not use the lozenges while lying down, e.g. at bedtime, due to the risk of choking.
• CW999

  Device should not be used during persisting traumas, e.g. after surgery or injuries of the mouth.
• CW999

  Device should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the lozenges
• CW999

  If allergic reactions occur, the use of the device must be discontinued immediately.

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Trade name

Granions® Mal de Gorge Intense

UDI-DI code

D-38123GQ

Basic UDI-DI

B-38123GQ

Reference / catalog number

38068

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

• PVC Blister pack (3 x 8 Lozenges)

• Q0399ENT DEVICES - OTHER

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