Eyeol UK Limited

Certificat C592935

Rév. 0Délivré

Valide jusqu'au: 11 févr. 2030

Le certificat C592935 est un certificat Système de management de la qualité valide délivré à Eyeol UK Limited et enregistré dans EUDAMED. Valable jusqu'au 11 février 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C592935
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: 2460C5929350

Validité

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

Organisme notifié

Organisme notifié: DNV Product Assurance AS
SRN de l'organisme notifié: 2460
Pays de l'organisme notifié: Norvège

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Oui
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: Non
Enregistrement initial: Oui
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Oui
Destination médicale: Non
RSCP applicable: Non
Conditions applicables: Non
MOS hors EUDAMED: —
Type SMQ/MOS: Classe IIb uniquement

Historique

Aucun changement de statut ni certificat précédent enregistré.

Périmètre de couverture

Classe IIb10

10 périmètres

Hydrophilic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Pseudophakic IOL is designed to meet refractive corrections following a cataract surgery, replacing natural lens. Pseudophakic IOL is implanted in the ciliary sulcus to correct residual post-operative refractive errors ie the purpose is, a phakic application with already an IOL implanted. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Hydrophilic IOL Phakic is intended to be positioned in the posterior chamber of the eye for refractive correction. It is implanted in sulcus. It is implanted in front of the natural lens. The natural lens is not removed and the position of the implant act as a refractive medium. The indications include Refractive surgery & Correction of refractive error. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision.
Classe IIb
Hydrophobic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Hydrophobic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision. Preloaded IOL is that the IOLs are supplied sterile inside injection system known as Lens delivery System (LDS). The LDS is made of Injector and Cartridge assembly. The Hydrophobic IOL is pre-loaded into the cartridge.
Classe IIb
Foldable Hydrophilic IOL
Classe IIb
Foldable Hydrophilic IOL -Psedo Phakic
Classe IIb
Foldable Hydrophilic IOL-Phakic
Classe IIb
Foldable Hydrophobic IOL
Classe IIb
Foldable Hydrophobic IOL-Prelaoded
Classe IIb

Documents

LanguesEN

Périmètre de couverture

Classe IIb10

10 périmètres

Hydrophilic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Pseudophakic IOL is designed to meet refractive corrections following a cataract surgery, replacing natural lens. Pseudophakic IOL is implanted in the ciliary sulcus to correct residual post-operative refractive errors ie the purpose is, a phakic application with already an IOL implanted. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Hydrophilic IOL Phakic is intended to be positioned in the posterior chamber of the eye for refractive correction. It is implanted in sulcus. It is implanted in front of the natural lens. The natural lens is not removed and the position of the implant act as a refractive medium. The indications include Refractive surgery & Correction of refractive error. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision.
Classe IIb
Hydrophobic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision, Multifocal IOL is used for near, intermediate and far vision and Toric IOL has an additional intended use to correct pre-existig astigmatism.
Classe IIb
Hydrophobic IOLs are intended to be implanted into the capsular bag in posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. The monofocal IOL is used for near or far vision. Preloaded IOL is that the IOLs are supplied sterile inside injection system known as Lens delivery System (LDS). The LDS is made of Injector and Cartridge assembly. The Hydrophobic IOL is pre-loaded into the cartridge.
Classe IIb
Foldable Hydrophilic IOL
Classe IIb
Foldable Hydrophilic IOL -Psedo Phakic
Classe IIb
Foldable Hydrophilic IOL-Phakic
Classe IIb
Foldable Hydrophobic IOL
Classe IIb
Foldable Hydrophobic IOL-Prelaoded
Classe IIb

Certificat C592935

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Périmètre de couverture

Documents

Certificat C592935

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Périmètre de couverture

Documents

Fabricant