EXTREMITER2020

Nom de l'organisation

EMBITRON s.r.o.

SRN

CZ-MF-000041086

Statut du fabricant

Actif

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Absolute contraindications: - acute conditions of venous thrombosis and embolism, suspected ; - aneurysm in the area of the treated limb (assessed as a risk of microembolisation from a local thrombus); - severe bleeding disorders and radial anticoagulant treatment; - acute open wounds with a serious risk of bleeding, risk of subcutaneous emphysema; - local purulent infections with a significant risk of spreading infectious agents and toxic tissue breakdown products, especially advanced necrosis (gangrene); - local malignant tumours, where the risk of spreading of tumour metastases could occur due to VCT; - limb oedema of cardiac, nephrogenic or hepatogenic origin; - Leiden mutation; - Pregnancy; - increased propensity for petechiae and haematomas at the site of the hermetic seal of the limb (oppression by the sealing cuff or the edge of the neck of the application cylinder); - psychiatric disorders not permitting closure of the limb in the applicator; - cardiac insufficiency associated with swelling; - septic conditions; - hyperthermia.
• CW011

  VCT is a medical method that is indicated and prescribed principally by a physician and administered by qualified and officially trained personnel - physiotherapist, a rehabilitation worker or nurse.

Marché principal en Tchéquie ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08596526110009

Basic UDI-DI

B-08596526110009

Numéro de référence/catalogue

EXTREMITER2020

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The purpose of the EXTREMITER 2020 is to administer physical treatment procedures of vacuum-compression therapy (VCT) with the aim of positively influencing organic and functional disorders of blood circulation in the limbs.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z120611VACUUM THERAPY EQUIPMENT

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