Biotech Europe Meditech Inc Limited

Certificat C537156

Rév. 1Délivré

Valide jusqu'au: 13 mai 2027

Le certificat C537156 est un certificat Système de management de la qualité valide délivré à Biotech Europe Meditech Inc Limited et enregistré dans EUDAMED. Valable jusqu'au 13 mai 2027. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: C537156
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: 2460C5371561

Validité

Délivré le: 13 mai 2022
Valide à partir du: 13 mai 2022
Valide jusqu'au: 13 mai 2027

Fabricant

Fabricant: Biotech Europe Meditech Inc Limited
SRN du fabricant: IE-MF-000004695
Pays du fabricant: Irlande

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 IIb12Classe IIa2

14 périmètres

Hydrophilic Acrylic Foldable Intraocular Lens Hydrophilic Single piece Intraocular Lenses are intended to be implanted into the capsular bag in the posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in adult patients with cataracts.
Classe IIb
Phakic Hydrophilic Intraocular Lens Phakic Intraocular Lenses are indicated in Phakic adults for the correction or reduction of Refractive error (myopia/ hyperopia).
Classe IIb
Phakic Toric Hydrophilic Intraocular Lens Phakic Toric Intraocular Lenses are indicated in Phakic adults for the correction or reduction of Refractive error (myopia/hyperopia) and refractive error with astigmatism.
Classe IIb
Hydrophobic Mono focal Intraocular Lenses Hydrophobic acrylic Intraocular Lenses are intended to be implanted into the capsular bag in the posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts.
Classe IIb
Hydrophobic Tri focal Intraocular Lenses Hydrophobic acrylic Intraocular Lenses are intended to be implanted into the capsular bag in the posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. Hydrophobic acrylic multifocal, multifocal Toric, Tri EDOF & Tri EDOF Toric Intraocular Lenses are also indicated for presbyopic patients who seeks greater independence from glasses for intermediate and/or near vision
Classe IIb
Preloaded Delivery System with Hydrophobic Intraocular Lenses Preloaded Hydrophobic acrylic Intraocular Lenses are intended to be implanted into the capsular bag in the posterior chamber of the eye for the visual correction of aphakia secondary to the removal of the crystalline lens in patients with cataracts. Preloaded Hydrophobic acrylic multifocal, multifocal Toric, EDOF & EDOF Toric Intraocular Lenses are indicated for presbyopic patients who seeks greater independence from glasses
Classe IIb
Intraocular Lens delivery system IOL delivery system is indicated for implantation of intraocular ens into the eye.
Classe IIa
MPS6, MPA6
Classe IIb
MPCK10, MPCK15, MPCK20, MPCK25, MPCK30, MPCK35, MPCK40, PKC110NH, PKC115NH, PKC120NH, PKC125NH, PKC130NH, PKC135NH, PKC140NH
Classe IIb
MPCKT10, MPCKT15, MPCKT20, MPCKT25, MPCKT30, MPCKT35, MPCKT40, PC110T, PC115T, PC120T, PC125T, PC130T, PC135T, PC140T
Classe IIb
MFA6
Classe IIb
3FLA6, 3FLA6T, 3FLA6E, 3FLA6ET
Classe IIb
LMFA6, LMFAC6, LMFAC6E, LMFAC6ET, LMF20E, LMF20ET
Classe IIb
OPTIJECT BES22, BES28, BES28P
Classe IIa

Documents

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