Biotech Europe Meditech Inc Limited

Certificate C537156

Rev. 1Issued

Valid until: May 13, 2027

Certificate C537156 is a valid Quality management system issued to Biotech Europe Meditech Inc Limited and registered in EUDAMED. Valid until May 13, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: C537156
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5371561

Validity

Issued: May 13, 2022
Valid from: May 13, 2022
Valid until: May 13, 2027

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb12Class IIa2

14 scopes

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.
Class IIb
Phakic Hydrophilic Intraocular Lens Phakic Intraocular Lenses are indicated in Phakic adults for the correction or reduction of Refractive error (myopia/ hyperopia).
Class 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.
Class 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.
Class 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
Class 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
Class IIb
Intraocular Lens delivery system IOL delivery system is indicated for implantation of intraocular ens into the eye.
Class IIa
MPS6, MPA6
Class IIb
MPCK10, MPCK15, MPCK20, MPCK25, MPCK30, MPCK35, MPCK40, PKC110NH, PKC115NH, PKC120NH, PKC125NH, PKC130NH, PKC135NH, PKC140NH
Class IIb
MPCKT10, MPCKT15, MPCKT20, MPCKT25, MPCKT30, MPCKT35, MPCKT40, PC110T, PC115T, PC120T, PC125T, PC130T, PC135T, PC140T
Class IIb
MFA6
Class IIb
3FLA6, 3FLA6T, 3FLA6E, 3FLA6ET
Class IIb
LMFA6, LMFAC6, LMFAC6E, LMFAC6ET, LMF20E, LMF20ET
Class IIb
OPTIJECT BES22, BES28, BES28P
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIb12Class IIa2

14 scopes

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.
Class IIb
Phakic Hydrophilic Intraocular Lens Phakic Intraocular Lenses are indicated in Phakic adults for the correction or reduction of Refractive error (myopia/ hyperopia).
Class 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.
Class 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.
Class 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
Class 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
Class IIb
Intraocular Lens delivery system IOL delivery system is indicated for implantation of intraocular ens into the eye.
Class IIa
MPS6, MPA6
Class IIb
MPCK10, MPCK15, MPCK20, MPCK25, MPCK30, MPCK35, MPCK40, PKC110NH, PKC115NH, PKC120NH, PKC125NH, PKC130NH, PKC135NH, PKC140NH
Class IIb
MPCKT10, MPCKT15, MPCKT20, MPCKT25, MPCKT30, MPCKT35, MPCKT40, PC110T, PC115T, PC120T, PC125T, PC130T, PC135T, PC140T
Class IIb
MFA6
Class IIb
3FLA6, 3FLA6T, 3FLA6E, 3FLA6ET
Class IIb
LMFA6, LMFAC6, LMFAC6E, LMFAC6ET, LMF20E, LMF20ET
Class IIb
OPTIJECT BES22, BES28, BES28P
Class IIa

Certificate C537156

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate C537156

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer