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T Com

EUDAMED

Class IIa (EU MDR)

Ref FP1025C2Model T Com C2

by Nexobio Co., Ltd.

Identity

Device Name
T Com EUDAMED
Model / Reference
T Com C2 EUDAMED
FP1025C2 EUDAMED

Identifiers

Primary DI / UDI-DI
08800032401224 EUDAMED
Basic UDI-DI
B-08800032401224 EUDAMED
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Dental composite resin

T Com by Nexobio Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Nexobio Co., Ltd.
EUDAMED SRN
KR-MF-000043543
Authorised Representative
Mega Diş Deposu /Mustafa Soydan-Mete Yılmaz TR-AR-000040213

Sources (1)

  • EUDAMED 86ce4c58-4fbf-49c4-a014-8c5d0b661a80 61 fields · synced Jun 19, 2026