Cyber Surgery S.L.

Certificat C608701

Rév. 1Délivré

Valide jusqu'au: 23 sept. 2030

Le certificat C608701 est un certificat Système de management de la qualité valide délivré à Cyber Surgery S.L. et enregistré dans EUDAMED. Valable jusqu'au 23 septembre 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C608701
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: 2460C6087011

Validité

Délivré le: 24 sept. 2025
Valide à partir du: 24 sept. 2025
Valide jusqu'au: 23 sept. 2030

Fabricant

Fabricant: Cyber Surgery S.L.
SRN du fabricant: ES-MF-000042958
Pays du fabricant: Espagne

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

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIa10Classe I10Classe IIb2

22 périmètres

Cyber Surgery Spine Robotic Assistant – Cyber Surgery Spine Robotic Assistant is a robotic assistant designed to be used on transpedicular screw planification for spinal fusion. The system guides the surgeon and facilitates the surgical procedure.
Classe IIb
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Classe IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Classe IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Classe IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Classe IIa
The Cyber Surgery Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform invasive steps of the clinical procedures.
Classe IIa
The Cyber Surgery Spine Fiducial - is a single-use, sterile (gamma radiation). The Cyber Surgery Spine Fiducial is intended for use with Cyber Surgery Spine Robotic Assistant as an aid during image registration process to perform the recording of the patient’s position by intraoperative imaging.
Classe I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Classe I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Classe I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Classe I
The Cyber Surgery Non-Invasive Surgical Instruments are reusable surgical instruments intended for use with Cyber Surgery Spine Robotic Assistant during the spinal surgery to perform non-invasive steps of the clinical procedures.
Classe I
ALAYA Spine Robotic Assistant
Classe IIb
ALAYA Spine Bone Clamps
Classe IIa
ALAYA Spine Dilator
Classe IIa
ALAYA Spine Awl
Classe IIa
ALAYA Spine Drill Guide
Classe IIa
ALAYA Spine K-Wire adapter
Classe IIa
ALAYA Spine Fiducial
Classe I
ALAYA Spine AB Tool Guide
Classe I
ALAYA Spine C Tool Guide
Classe I

1 / 2

Documents

LanguesEN