Surgical accessories

by ZIACOM ITS S.r.l. 130 variants

Ref KLR 4310 LModel Surgical accessories

Active European Union

CE MDR

Valid until

21 Jan 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier ICIM S.P.A.

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	Number805957100ACCESSORICL.1MV Basic UDI-DI 08059571007194UDI-DI	Date11 May 2026Registered	StatusActive
European Union	CE/MDR	Number0425-MDR-030118-02	Date17 Apr 2026Issued	StatusActive expires 21 Jan 2030

Certificates

1 certificate · EUDAMED

0425-MDR-030118-02 Active

Quality management system EU MDR

Certifier

ICIM S.P.A. 0425

Issued
17 Apr 2026

Expires
21 Jan 2030

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Surgical accessories
Model / Reference: Surgical accessories, KLR 4310 L

Primary DI / UDI-DI: 08059571007194
Basic UDI-DI: 805957100ACCESSORICL.1MV
EMDN Code: Q010207 Dental impression devices for prosthetic dentistry

Device Class: Class I
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000028897

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See all devices from ZIACOM ITS S.r.l. →

Properties

Reusable

Other properties (12)

Sterile: No
Implantable: 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