41059000

Nom de l'organisation

Penta Arzneimittel GmbH

SRN

DE-MF-000006565

Statut du fabricant

Actif

11 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW007

  Do not use the product if single dose container is damaged.
• CW032

  Do not use the eye drops beyond the expiry date which you can find on each single dose container and on each folding box.
• CW010

  Consult instructions for use.
• CW036

  If you also use other eye drops / eye ointment, wait about 15 minutes. These eye drops should always be used last.
• CW135

  The eye drops are filled into small plastic containers which could be swallowed by small children. Therefore, please keep the product out of the reach of children.
• CW137

  Do not use in infected and injured eyes. Important information for users with severe corneal damage: In very rare cases, deposits of calcium phosphate on the cornea have been reported during the use of phosphate-containing eye drops.
• CW008

  Do not touch the eye with the single dose container.
• CW129

  Do not use if you are allergic to any of the ingredients.
• CW304

  In very rare cases, the use of the eye drops may cause irritation in very sensitive eyes or eye lids. The following eye disorders may occur: redness, pain, burning, stinging, itching, swelling, foreign body sensation.
• CW011

  Temporary blurring for a brief period may be experienced after application; avoid driving, operating machinery and wait until normal vision is restored.
• 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.

Marché principal en Suède ; disponible dans 3 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

14260595531775

Basic UDI-DI

426059553MP01UD01HQ

Numéro de référence/catalogue

41059000

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Sodium Hyaluronate 0.15% Eye Drops (single dose container, 0.35ml) care for and moisturise the ocular surface and alleviate the symptoms of Dry Eye Syndrome.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES