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Name: Ena Bond Model: Catalyst/Light curing bonding

EUDAMED

Class IIa (EU MDR)

Ref COSM300D-2

by Micerium S.p.A.

Identity

Device Name
Name: Ena Bond Model: Catalyst/Light curing bonding EUDAMED
Model / Reference
COSM300D-2 EUDAMED

Identifiers

Primary DI / UDI-DI
EMICCOSM300D21 EUDAMED
Basic UDI-DI
++EMICFAM1AV7 EUDAMED
EMDN Code
Q01010104 DENTAL BONDING AGENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy 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

Category: Dentine bonding agent/set

Name: Ena Bond Model: Catalyst/Light curing bonding by Micerium S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Micerium S.p.A.
EUDAMED SRN
IT-MF-000010187

Sources (1)

  • EUDAMED e171864a-3ad4-4d2f-b959-b1cc0205bf42 61 fields · synced Aug 3, 2026