Atos Medical AB

Certificat C520850

Rév. 3Délivré

Valide jusqu'au: 11 févr. 2030

Le certificat C520850 est un certificat Système de management de la qualité valide délivré à Atos Medical AB et enregistré dans EUDAMED. Valable jusqu'au 11 février 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C520850
Type de certificat: Système de management de la qualité
Statut du certificat: Délivré
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 1
Identifiant du certificat: 2460C5208503

Validité

Délivré le: 12 févr. 2025
Valide à partir du: 12 févr. 2025
Valide jusqu'au: 11 févr. 2030

Fabricant

Fabricant: Atos Medical AB
SRN du fabricant: SE-MF-000000725
Pays du fabricant: Suède

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

: Oui
: Non
: Non
: Non
: Oui
: Non
: Non
: Oui
: Oui
: Non
: Non
: Non

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIa12Classe IIb10Classe I2

24 périmètres

Sterile single-use dressing
Classe I
TrachPhone is a single use Heat and Moisture Exchanger (HME) which is intended for pulmonary rehabilitation in patients selfventilating through a tracheostoma.
Classe IIa
Provox Life Oxygen is a single-use accessory to Provox Life HMEs. It allows additional oxygen supply for patients breathing through a tracheostoma using Provox Life HMEs.
Classe IIa
Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. The Provox Insertion System is a sterile single use device intended for anterograde replacement of the Provox Vega voice prosthesis. This replacement procedure is carried out by a medical professional in accordance with local
Classe IIb
Provox Vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is performed by the patient while it remains in situ. The Provox Insertion System is a sterile single use device intended for anterograde replacement of the Provox Vega voice prosthesis. This replacement procedure is carried out by a medical professional in accordance with local
Classe IIb
Provox XtraFlange is a silicone washer intended to reduce periprosthetic leakage that is detected on patients using indwelling Provox voice prostheses. Placement is performed by a medical doctor or a trained medical professional in accordance with local or national guidelines.
Classe IIb
The Provox2 Voice Rehabilitation System is intended for use in surgical, prosthetic voice restoration after total laryngectomy. The prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis.
Classe IIb
The Provox NiD voice rehabilitation system is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision. The Provox NiD is intended for single patient use.
Classe IIb
The Provox GuideWire is a sterile single use insertion device intended for placement of a sterile Provox indwelling Voice Prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling Voice Prosthesis.
Classe IIa
Provox Plug is intended to seal the inner lumen of Provox2 voice prosthesis and Provox ActiValve and therefore stop leakageof both air and fluids through the voice prosthesis. Provox Vega Plug is intended to seal the inner lumen of Provox Vega voice prosthesis and therefore stop leakage of both air and fluids through the voice prosthesis.
Classe IIa
The Provox Dilator is intended to dilate or stent the tracheoesophageal puncture in laryngectomized patients.
Classe IIa
The Provox Dilator 17 and 20 is intended to dilate or stent the tracheoesophageal puncture in laryngectomized patients.
Classe IIa
Freevent Dressing Softfoam
Classe I
TrachPhone
Classe IIa
Provox Life Oxygen
Classe IIa
Provox Vega
Classe IIb
Provox Vega XtraSeal
Classe IIb
Provox XtraFlange
Classe IIb
Provox2 Voice Prosthesis
Classe IIb
Provox NID
Classe IIb

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