Control Lubgel Infinity2 EN

by Artsana S.p.A.

Ref 00011222000100

Active European Union

CE MDR

Valid until

1 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number805866409635000SM Basic UDI-DI 08058664099825UDI-DI	Date5 Mar 2024Registered	StatusActive
European Union	CE/MDR	NumberCSQ001423	Date2 Nov 2023Issued	StatusActive expires 1 Nov 2028

Certificates

1 certificate · EUDAMED

CSQ001423 Active

Quality management system EU MDR

Certifier

ISTITUTO SUPERIORE DI SANITA' 0373

Issued
2 Nov 2023

Expires
1 Nov 2028

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Silicone based intimate lubricating gel
Model / Reference: 00011222000100

Primary DI / UDI-DI: 08058664099825
Basic UDI-DI: 805866409635000SM
Direct Marketing DI: 08058664099825
EMDN Code: V9099 Various devices not included in other classes - other

Device Class: Class IIb
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000010731

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LYCIAS Class 70 den Nudo - 2

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Class I

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No