41108000

Organization name

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Manufacturer status

Active

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

• CW007

  Do not use if the bottle or spray head is damaged.
• CW032

  Do not use the nasal spray beyond the expiry date which you can find on each bottle and on each folding box.
• CW010

  Consult instructions for use.
• CW036

  If you also use other nasal preparations (sprays, drops, ointments, etc.), you should use them at least 30 minutes apart.
• CW135

  Keep the product out of the reach of children.
• CW011

  Do not use after nasal surgery and injuries in the nasal area.
• CW129

  Do not use if you are hypersensitive to any of the ingredients.
• CW999

  In rare individual cases, a slight burning sensation may occur immediately after use.
• CW277

  In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.

Primary placement in Sweden; available across 3 countries total.

Trade name

not provided

UDI-DI code

14260595531959

Basic UDI-DI

426059553MP313K01CT

Reference / catalog number

41108000

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Aloe Vera Nasal Spray (multi dose container, 15ml) moisturises, cleanses and cares for dry, irritated and encrusted nasal mucous membranes.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q030103NASAL IRRIGATION SOLUTIONS