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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

IBSA FARMACEUTICI ITALIA SRL

Certificate EPT 0477.MDR.22/4843

Rev. 2Issued

Valid until: Jun 6, 2027

Overview

Certificate number: EPT 0477.MDR.22/4843
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0477EPT 0477.MDR.22/48432

Validity

Issued: Mar 11, 2025
Valid from: Mar 11, 2025
Valid until: Jun 6, 2027

Manufacturer

Manufacturer: IBSA FARMACEUTICI ITALIA SRL
Manufacturer SRN: IT-MF-000008111
Manufacturer country: Italy

Notified body

Notified body: Eurofins Product Testing Italy S.r.l.
Notified body SRN: 0477
Notified body country: Italy

Covered devices

SODIUM HYALURONATE 2.4% and SODIUM CHONDROITIN 1.6% - VISCO-SUPPLETIVE JOINT DEVICEClass III
803363895IA0024T

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

SODIUM HYALURONATE 2.4% and SODIUM CHONDROITIN 1.6% - VISCO-SUPPLETIVE JOINT DEVICE
803363895IA0024T

Documents

LanguagesENIT