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Elite

EUDAMED

Class I (EU MDR)

Ref ED-025-008

by Medixdent International

Identity

Trade Name
Elite EUDAMED
Device Name
Explorers EUDAMED
Model / Reference
ED-025-008 EUDAMED

Identifiers

Primary DI / UDI-DI
+G359ED0250080U EUDAMED
Basic UDI-DI
++G359Explorers2M EUDAMED
Direct Marketing DI
+G359ED0250080U EUDAMED
EMDN Code
L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Elite by Medixdent International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
PK-MF-000027173
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 2a0624d4-a01a-4f4f-90ba-9ce7b26f1a26 61 fields · synced Jun 20, 2026