mark'ennovy Personalized Care S.L.

Certificate ES25/00001111

Rev. 2Supplemented

Valid until: Oct 23, 2030

Certificate ES25/00001111 is a valid Quality management system issued to mark'ennovy Personalized Care S.L. and registered in EUDAMED. Valid until October 23, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: ES25/00001111
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639ES25/000011112

Validity

Issued: Dec 16, 2025
Valid from: Dec 16, 2025
Valid until: Oct 23, 2030

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

ES25/00001111Quality management systemIssuedOct 23, 2025 → Oct 23, 2030

Scope coverage

Class IIa6

6 scopes

MDN 1206, MDS 1005
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Methafilcon hydrogel lathed contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel lathed contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Gentle hydrogel contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. GMA & 2-HEMA hydrogel contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel moulded contact lens
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa6

6 scopes

MDN 1206, MDS 1005
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Methafilcon hydrogel lathed contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel lathed contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Gentle hydrogel contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. GMA & 2-HEMA hydrogel contact lenses
Class IIa
Sterile Contact Lenses for the correction of myopia, hypermetropia, and presbyopia, with or without astigmatism & Myopia Management Contact Lenses for the correction of myopia, with or without astigmatism, and to reduce its progression. Silicone hydrogel moulded contact lens
Class IIa

Certificate ES25/00001111

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate ES25/00001111

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer