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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

Farmigea S.p.A.

Certificate 56317

Rev. 1Reissued

Valid until: Nov 27, 2028

Overview

Certificate number: 56317
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0546563171

Validity

Issued: Nov 28, 2023
Valid from: Dec 20, 2023
Valid until: Nov 27, 2028

Manufacturer

Manufacturer: Farmigea S.p.A.
Manufacturer SRN: IT-MF-000018521
Manufacturer country: Italy

Notified body

Notified body: CERTIQUALITY S.r.l.
Notified body SRN: 0546
Notified body country: Italy

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Supersedes

56317Quality management systemIssuedNov 28, 2023 → Nov 27, 2028

Scope coverage

Class IIb2

2 scopes

Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route.
Class IIb
Sterile ophthalmic solutions containing Lissamine Green for the ocular surface epithelium staining.
Class IIb

Documents

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