proctoLYSYAL®

by SILDEHA Pharma Srl

Ref 0SLD700C2G

Active European Union

CE MDR

Valid until

18 Jan 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number805720449TLYSCREPRO2R Basic UDI-DI 08057204490139UDI-DI	Date1 Apr 2026Registered	StatusActive
European Union	CE/MDR	NumberCSQ0005230326	Date31 Mar 2026Issued	StatusActive expires 18 Jan 2028

Certificates

1 certificate · EUDAMED

CSQ0005230326 Active Supplemented

Quality management system EU MDR

Certifier

ISTITUTO SUPERIORE DI SANITA' 0373

Issued
31 Mar 2026

Expires
18 Jan 2028

Reason
Add device or group

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: T-LysYal® Crema Proctologica
Model / Reference: 0SLD700C2G

Primary DI / UDI-DI: 08057204490139
Basic UDI-DI: 805720449TLYSCREPRO2R
EMDN Code: M040499 Dressings for wounds, sores and ulcerations - other

Device Class: Class IIb
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000026622

Other devices from SILDEHA Pharma Srl

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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